(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: innova 6.0x150, life stent 7.0x200, supera 6.0x150.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the absolute pro instruction for use, as a known patient effect associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, 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.The supera stent is being filed under a separate medwatch report.
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It was reported that on (b)(6) 2019, after angiography and intravascular ultrasound (ivus), aspiration thrombectomy was performed.An absolute pro stent was placed in the right common iliac artery and a supera self expanding stent (ses) was placed in the right superficial femoral artery.Two non-abbott stents were also placed in the right leg.On (b)(6) 2019, no pulse could be identified on the patient's right leg so an angiography was performed that confirmed acute thrombotic occlusion in the supera and absolute pro stents.There was no treatment performed.Reportedly, the other non-abbott stents similarly resulted in acute thrombus occlusion.No treatment was performed; however, bypass is scheduled in the future.The patient outcome is reported as "not recovered".No additional information was provided.
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