Date of event will be documented as (b)(6) 2022, 5 years post index procedure when stent was implanted.The udi number is ¿unk¿ as the catalog and lot number were not provided.The scaffold remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The data from the additional 5 patients referenced is being reported under separate medwatch report #s.Attachment: article titled, 'structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up.
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It was reported that 31 consecutive patients treated with absorb-bvs underwent a structural and functional evaluation of the coronary arteries at the 5-year follow-up.Patients were selected from a multicenter registry of consecutive absorb-bvs recipients and the present analysis reports the imaging and vasomotor reactivity testing results of the 31 patients at =5 years postimplant.Those patients who had <5 years follow-up from the implantation time point have been reported in a separate analysis.The follow-up was 60.5 ± 4.6 months.A total of 5 patients underwent new percutaneous coronary intervention (pci), 3 of whom were performed on scaffolded arteries.A late thrombosis of the device and a restenosis at 6 months of follow-up were described.Please see attached article titled, 'structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up.
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The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of restenosis, thrombosis, hypotension, cerebrovascular accident and myocardial infarction, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effects, and the 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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