(b)(4).There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.The reported patient effects of ischemia and thrombosis are listed in the supera instructions for use as known patient effects.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the lot number was not reported.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.The additional non-surgical treatment and hospitalization was related to operational context.
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It was reported the 5.0x120mm supera stent was implanted on (b)(6) 2018 in a lesion in the left leg with no issues.On (b)(6) 2018, the patient presented with a cold leg and acute shut down of the supera stent was noted.Thrombolysis was performed and two absolute stents were deployed, one distal and one proximal to the supera stent.The patient was stable and the final patient outcome was good.No additional information was provided.
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