Catalog Number UNK SUPERA |
Device Problems
Stretched (1601); Defective Device (2588); Patient-Device Incompatibility (2682)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2010 |
Event Type
malfunction
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Manufacturer Narrative
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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 numbers were not provided.The investigation determined a conclusive cause for the reported stretched-stent, the reported patient-device incompatibility-recoil and the reported defective device-shortened cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2, b3, b6, d6: dates estimated the additional death and patient effects reported in the article(s) are captured under separate medwatch reports.Attachment: literature titled, ivus improves outcomes with supera stents for the treatment of superficial femoral-popliteal artery diseasena.
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Event Description
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It was reported through a research article that 350 patients were treated for endovascular disease in a single center; however, 200 patient's that were confirmed with femoropopliteal peripheral artery disease (pad) were all treated with supera self-expanding stents.This study was conducted to determine the effects of the intravascular ultrasound (ivus) when used adjunctively with nitinol interwoven bare metal stent and 91 patients received adjunctive ivus imaging prior to stent deployment.Deployment conditions were noted as compressed and elongation with some complications listed (total occlusion, dissection, thrombus, recoil, perforation).Follow up outcomes were noted as target lesion reintervention, amputation and mortality.The patients who received ivus had a greater number of nominally deployed stents and lower reintervention rates compared with those who did not received ivus imaging.The ivus and angiography may decrease clinically-driven target lesion reintervention and may increases nominal deployment compared with angiography alone.Specific patient information is documented as unknown.Details are listed in the attached article, titled "ivus improves outcomes with supera stents for the treatment of superficial femoral-popliteal artery disease" no additional information was provided.
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Search Alerts/Recalls
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