(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.The reported patient effects of cardiac arrest and perforation, as listed in the absorb gt1, electronic instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the ifu states: the absorb gt1 bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.
|
It was reported that the procedure was to treat a saphenous vein graft.A 3.5 x 28 mm absorb gt1 scaffold was deployed at 14 atmospheres; however, angiography revealed a perforation.Two graftmaster covered stents (3.5 x 18 mm and 3.5 x 26 mm) were successfully used to seal the perforation.The patient had to have blood transfusions, received cardiopulmonary resuscitation (cpr) and was put on an intra-aortic balloon pump.There was a clinically significant delay in the procedure.No additional information was provided.
|