Date of event has been estimated as (b)(6) 2022, 5 years post index procedure when stent was implanted.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled, ''structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up'.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
|
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 post implant.Those patients who had <5 years follow-up from the implantation time point have been reported in a separate analysis.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.The follow-up was 60.5 ± 4.6 months.For this patient, restenosis of the device occurred and percutaneous coronary intervention (pci) was performed.Please see attached article, titled 'structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up'.
|
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 effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effect, 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.
|