Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Same case as mdr id: 2134265-2016-00158, 2134265-2016-00159 and 2134265-2016-00160.It was reported that a vessel dissection occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery (lad).The lesion was predilated with a 2.25x12mm emerge balloon at 6atms for 15 seconds.A 2.25x20mm synergy ii stent was delivered to the mid lad and the physician deployed the stent at 16atms for 32 seconds; however, it was noted that the angiogram showed that there was no stent on the delivery system but this was not noticed at the time of deployment.Subsequent images were taken, displaying a "balloon-like" result.The physician and cath lab staff questioned whether the stent had embolized and traced the catheter and wire back through the guide catheter and sheath into the right femoral artery and found no evidence of the stent within the patient.Another physician was consulted and both physicians agreed that the stent had embolized but they were unsure of where the stent ended up.A 2.50x12mm emerge balloon was then used to post dilate the lesion, followed by a dissection in the mid lad.A longer 2.25x24mm synergy ii stent was selected to treat the lesion and the dissection, but after removal from the packaging and stent protector it was noted that there was no stent on the catheter shaft.There was some confusion amongst the physician and staff as to whether or not the stent was on the catheter and it was decided to the insert the device and advance it to the lesion.Again, angiography determined that there was no stent on the catheter shaft and the catheter was removed from the patient.A third 2.25x24mm synergy ii stent was prepped and delivered to the lesion.Once the stent was in place it was noted that it had foreshortened and was deformed on the delivery system as noted by angiography.The foreshortening occurred from the proximal edge of the stent along the shaft and was "accordioned" towards the distal tip of the catheter, roughly 5-7mm, appearing as a 15-18mm stent rather than a 24mm stent.At this point, the physician removed the synergy ii stent delivery system and advanced a 2.25x20mm promus premier stent to the lesion.The stent was determined by angiography to be intact and it was deployed at 12atms for 7 seconds in the mid lad.A second 2.25x28mm promus premier stent was also prepped and delivered to the lesion site, which had been extended because of the previous dissection.This stent was also determined to be intact by angiography and it was deployed at 15atms for 20 seconds.Post dilation was completed with a 2.5x12mm emerge balloon.The balloon was inflated at 12atms for 7 seconds, 15atms for 9 seconds, 15atms for 14 seconds, 15atms for 8 seconds and 16atms for 18 seconds, working distal to proximal within the stented area.300mg of clopidogrel was administered and procedure was completed.Final angiograms demonstrated a "beautiful" result with no further issues or patient complications.
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