(b)(4). The acs multi-link rx ultra coronary stent system (part 1003382-13, lot 00211441) indicated is being filed under a separate medwatch mfr number. Eval summary: factors that can contribute to difficulty deploying a stent due to stent recoil can include, but are not limited to, pt's anatomical morphology, lesion characteristics, pt's disease state, pre-dilatation strategy, inflation technique, product size selection, and/or lesion size. Failure to seal the perforation (the reported leak) may be attributed to several factors including, but not limited to, stent graft foil damage, pt anatomical morphology, product size selection, deployment technique (non-central positioning of stent graft over perforation or inadequate overlapping), interference from previously deployed devices, or growth of perforation during deployment. In this case, it is possible that the graft master stent was too small for the vessel, resulting in difficulty fully apposing the stent to the vessel wall, which may have contributed to the reported stent recoil and further contributing to the failure to seal the perforation; however, this could not be confirmed. It was also reported that after the graftmaster stent was deployed, the perforation was not sealed, and the pt was sent to surgery in an attempt to control the bleeding; however, the pt expired. Due to the inherently serious and emergent use of the graftmaster device, the perforation itself and/or the failure to treat the perforation may have possibly resulted in cascade of pt effects and additional treatments, which ultimately lead to death. Death is a known adverse event as listed in the instructions for use (ifu) and may also be related to the pt's overall health condition, pt disease state and/or treatment strategy at any stage of the perforation. A conclusive cause for these reported pt effects and their relationship to the device, if any, could not be determined. A conclusive cause for the difficulty deploying the stent and failure to seal the perforation could not be determined. A review of the lot history records did not reveal any non-conforming material records associated with this lot and all lot release testing met mfg criteria. During mfg, all stent delivery systems are 100% leak-tested and visually inspected for foil damage and proper placement.
It was reported that after deployment of a 5. 0 x 13 mm rx ultra stent in a saphenous vein graft to the right coronary artery lesion, a perforation occurred requiring the placement of a graftmaster stent. Initially, the perforation was sealed; however, approx 4-6 hours post procedure, the bleeding restarted and it was found that the graftmaster stent had recoiled. The pt was sent to surgery; however, the attempts to control the bleeding were unsuccessful and the pt expired. Pt's death occurred on (b)(6)2010. No additional event or pt info is available.