The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It is possible that the clamp seal was not entirely closed; thus resulting in the reported leak; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as the y-connector had to be held throughout the procedure in order to stop the leakage.There is no indication of a product quality issue with respect to manufacture, design or labeling.The graftmaster referenced is being filed under a separate medwatch report number.
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H10: medical device problem code 2017- above rated burst pressure.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the stent delivery system (sds) was deployed at 18 atmospheres (atm).It should be noted that the xience skypoint instructions for use (ifu) specifies the rated burst pressure (rbp) is 16 atm.It is unknown if the ifu deviation contributed to the reported event.The reported patient effects of pericardial effusion and perforation of vessels are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficult stent activation.Additionally, a conclusive cause for the reported patient effect(s), and their relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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