THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE SUPERA INSTRUCTION FOR USE AS A POTENTIAL ADVERSE EFFECT OF PERIPHERAL PERCUTANEOUS INTERVENTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE SUPERA INSTRUCTION FOR USE AS A POTENTIAL ADVERSE EFFECT OF PERIPHERAL PERCUTANEOUS INTERVENTION. BASED ON THE INFORMATION PROVIDED, A CONCLUSIVE CAUSE FOR THE REPORTED STENT MATERIAL DEFORMATION AND SUBSEQUENT PATIENT EFFECTS COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THAT THE SUPERA STENT WAS SUBJECTED TO STRESS/FATIGUE OR REPETITIVE MOVEMENT DUE TO ANATOMICAL CONDITIONS AND LOCATION OF THE IMPLANT; HOWEVER, THIS COULD NOT BE CONFIRMED. THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, SURGICAL PROCEDURE, TREATMENT WITH MEDICATIONS AND HOSPITALIZATION WERE DUE TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THE SUPERA SELF EXPANDING STENT (SES) APPEARED TWISTED 7 MONTHS AFTER IT WAS IMPLANTED IN A VEIGN GRAFT BYPASS POPLITEAL SEGMENT. THE PATIENT WAS RE-HOSPITALIZED AND TREATED WITH OVERNIGHT THROMBOLYSIS FOR THE BLOCKED GRAFT. THERE WAS A THROMBUS ABOUT 10 CM ABOVE THE STENT AND WAS CONFIRMED WITH ANGIOGRAPHY. THROMBUS WAS DISCOVERED BECAUSE THE PATIENT WAS EXPERIENCING REST PAIN. IT WAS ATTEMPTED TO UNTWIST THE STENT WITH BALLOON ANGIOPLASTY AS WELL AS PLACING AN ADDITIONAL STENT. THE PATIENT HAS BEEN REFERRED TO VASCULAR SURGERY TO CONSIDER OPTIONS. THE PHYSICIAN REMARKED THAT THEY WERE PLEASED WITH THE PERFORMANCE OF THE SES. NO ADDITIONAL INFORMATION WAS PROVIDED.