The recall of all of Maquet's 4,154 TigerPaw Systems II caps a horrendous year for the company, which in February experienced a permanent injunction from the Department of Justice that resulted in the halt of manufacturing at one of its facilities, the temporary suspension of 5 of its devices from the market, and a $6 million fine for violating Quality System good manufacturing regulations.
In addition, the incident raises serious questions about the FDA's device classification decisions.
The TigerPaw left atrial appendage occlusion device is supposed to prevent stroke. Maquet asked that it be removed and quarantined due to increased reports of possible tissue tearing of the atrial wall and bleeding during use of the device. There were 51 reported adverse events and one death from the complications.
In fact, these risks from left atrial appendage occlusion were well known. Just ask Boston Scientific ($BSX). Concerns about those adverse events occurring during its device's difficult implantation surgery stymied the company's attempts to commercialize its Watchman left atrial appendage occlusion device for years; the device was finally approved via the stringent PMA pathway this year, after suffering a rejection 2010 due to concerns about procedural complications.
Mayo Clinic Cardiologist Dr. David Holmes, who's studied the Watchman extensively, told FierceMedicalDevices that the risk of bleeding in the pericardium sac from a laceration to the left atrial appendage is around 2%.
The point is, the TigerPaw never received such scrutiny because it strolled through the far easier 510(k) clearance pathway. Submitting a 510(k) application costs about $5,000 compared to about $250,000 for a PMA (though that's pennies compared the cost of carrying out the required clinical trials and gathering other data).
Unlike most 510(k) cleared devices, the TigerPaw did undergo a 60-person, 90-day clinical study, according to the device's 510(k) notice, but that's compared to a numerous multi-year studies of 2,400 patients for the Watchman.
Apparently, the TigerPaw was deemed a low-to-moderate risk device. "This (left atrial appendage occlusion) is one of the most complex procedures that you could perform in our field," Dr. Jay Giri, intervention cardiologist at University of Pennsylvania Health System told the Minneapolis StarTribune. "The question now becomes, why would that possibly be the case?"
He was actually referring to another "intermediate risk" 510(k)-cleared device that was used for left atrial appendage occlusion--SentreHeart's Lariat, which also turned out to have undisclosed risks that resulted 6 patient deaths, and an FDA letter advising against use of the device.
The Lariat was never indicated specifically for left atrial appendage occlusion, but the TigerPaw's failures can't be attributed to off-label usage.
It was cleared for "occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures."
The FDA explained its rationale to FierceMedicalDevices, saying, "The TigerPaw System II is a class II moderate-risk device because it is substantially equivalent to a surgical staple that is used in patients undergoing conventional open heart surgery for other reasons. The procedures to implant the two devices are different. The TigerPaw is indicated to be placed in conjunction with other open cardiac procedures. In contrast, the Watchman is used in a stand-alone procedure and implanted using a catheter delivery system inserted via a blood vessel in the leg."
Because the TigerPaw is indicated to be implanted in conjunction with other open cardiac procedures, "the incremental risk to the patient is not nearly as high since he or she is already having an open heart procedure. In the case of the Watchman, because it is inserted via a standalone procedure, all risk incurred by the procedure needs to be balanced by the effectiveness of the device," the FDA said.
FDA deems all 4,000+ of troubled Maquet's left atrial appendage closure devices potentially deadly, announces major recall
FDA's regulatory decisions can be a headscratcher, as evidenced by these implants to fight stroke
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Watchman study author says it's better than warfarin at preventing hemorrhagic stroke
Boston Sci's stroke-fighting Watchman overcomes years of regulatory roadblocks, wins FDA approval
DOJ issues permanent injunction against German devicemaker for violating FDA regs
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