Catalog Number UNK SUPERA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Occlusion (1984); Pain (1994); Stenosis (2263); Claudication (2550)
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Event Date 10/13/2014 |
Event Type
Injury
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Manufacturer Narrative
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Age: mean age.Sex: majority gender.The device is not returning for analysis.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional supera device is filed under a separate medwatch report number."stenting of femoropopliteal lesions using interwoven nitinol stents" (b)(4).
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Event Description
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It was reported through a research article that the 5.5mm and 6.5mm supera stents may be related to claudication, rest pain, tissue loss (non-healing ulcers and gangrene), restenosis, occlusion, re-intervention including laser atherectomy, percutaneous transluminal angioplasty, additional stent placement, and femoropopliteal bypass.Specific patient information is documented as unknown.Details provided in the article titled: " "stenting of femoropopliteal lesions using interwoven nitinol stents".
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Manufacturer Narrative
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D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.In this case, there was no reported device malfunction associated with the supera self-expanding stent system (sess).The reported patient effects of worsening claudication, pain, ischemia, restenosis and occlusion are listed in the supera instructions for use as known potential adverse patient effects of peripheral percutaneous intervention.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Manufacturer Narrative
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This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na - attachment: [e-24081 article nms (1).Pdf].
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Search Alerts/Recalls
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