Catalog Number UNK SUPERA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160)
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Event Date 12/05/2023 |
Event Type
Injury
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Event Description
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It was reported through a research article identifying supera that may be related to the following: stenosis, occlusion, dissection, elongation, compression, malapposition, invagination, and amputation.This is a systematic review for articles published from december 2011 up to may 2021 regarding studies assessing the safety and efficacy of supera interwoven nitinol stent for the treatment of infra-inguinal peripheral artery disease.Details are in the attached article titled, "a systematic review and meta-analysis of supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease".
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Manufacturer Narrative
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B3: date of implant estimated as 12/05/2023.D4: the udi is unknown because the part/lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of stenosis, occlusion and dissection, are listed in the supera peripheral stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported stenosis, occlusion, intimal dissection, and the relationship to the product, if any, cannot be determined.The 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.The reported device malfunctions referenced in b5 are being filed under a separate medwatch report #.Attachment: article titled, 'a systematic review and meta-analysis of supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease'na.
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Search Alerts/Recalls
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