BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1894860 · Received November 10, 2010

    Report

    Report Number
    9616099-2010-00853
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 18, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INDEPENDENT PHYSICIAN FILM REVIEW. HISTORY: THIS COMPLAINT INVOLVES A PATIENT WHO UNDERWENT ENDOVASCULAR TREATMENT OF A LONG SEGMENT LEFT SUPERFICIAL FEMORAL ARTERY STENOSIS. INITIAL TARGET LESION WAS LONG SEGMENT STENOSIS WITH LUMINAL STENOSIS OF UP TO 90%. FOLLOWING A SUBOPTIMAL ANGIOPLASTY RESULT, THE TREATING PHYSICIAN DECIDED TO PLACE SEVERAL SMART STENTS IN THE LEFT SFA. TEN MONTHS FOLLOWING THE INDEX PROCEDURE, THE PATIENT RETURNED WITH RECURRENT SYMPTOMS. IT WAS NOTED THAT THE STENTS WERE OCCLUDED. THE PHYSICIAN BELIEVED THAT THE ETIOLOGY OF THE OCCLUSION WAS MYOINTIMAL HYPERPLASIA AND POOR ARTERIAL OUTFLOW. NEVERTHELESS, DURING INSPECTION OF THE STENT, IT WAS NOTED THAT ONE OF THE STENTS HAD FRACTURED. THERE WAS NO SIGNIFICANT STENT MIGRATION OR SEPARATION. THE OCCLUSION WAS TREATED WITH MECHANICAL THROMBECTOMY AND RE-STENTING AND THE PATIENT RECOVERED WELL. OBSERVATIONS: A SINGLE CD-ROM CONTAINING SEVERAL CINE FILES IS SUBMITTED FOR REVIEW. THERE ARE THREE SMART STENTS IN PLACE WITHIN THE LEFT SFA. WITHIN THE MID-PORTION OF THE MIDDLE STENT (AT THE LEVEL OF THE MID THIGH) THERE IS A FRACTURE OF THE STENT WITH MINIMAL SEPARATION. IT IS UNCLEAR WHETHER THE FRACTURE IS COMPLETE OR INCOMPLETE. FOLLOWING MECHANICAL THROMBECTOMY AND ANGIOPLASTY, THERE IS RESTORATION OF A FLOW LUMEN. NO CONTRAST EXTRAVASATION IS SEEN AT THE LEVEL OF THE STENT FRACTURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. CONCLUSION: THIS COMPLAINT INVOLVES A PATIENT WHO HAD MULTIPLE STENTS PLACED FOR TREATMENT OF LONG SEGMENT LEFT SFA DISEASE. AT 10 MONTHS FOLLOWING STENT PLACEMENT, THE PATIENT RETURNED WITH STENT OCCLUSION. DURING TREATMENT, IT WAS NOTED THAT ONE OF THE STENTS HAD FRACTURED. ALTHOUGH STENT PLACEMENT IN THE SUPERFICIAL FEMORAL ARTERY IS TECHNICALLY AN "OFF-LABEL" USE, IT IS PERFORMED COMMONLY DURING PERIPHERAL ARTERY ENDOVASCULAR THERAPY. THE SFA IS A VERY COMPLICATED VESSEL TO TREAT BECAUSE OF THE COMPLEXITY OF MOTION ASSOCIATED WITH THE LEGS. THE SFA IS CONSTANTLY EXPOSED TO FORCES OF LONGITUDINAL EXPANSION AND COMPRESSION, TORSION, ANGULATION, AND EXTRINSIC COMPRESSION. METAL FATIGUE LEADING TO STENT FRACTURE IS A WELL KNOWN POTENTIAL COMPLICATION OF PLACING STENTS IN HEAVILY DISEASED SUPERFICIAL FEMORAL ARTERIES. THIS POTENTIAL IS FURTHER EXACERBATED WITH SEVERE MYOINTIMAL HYPERPLASIA AS DEMONSTRATED IN THIS CASE. IN MY OPINION, I DO NOT BELIEVE THAT THIS CLINICAL EVENT WAS CAUSED BY SPECIFIC ISSUES IN STENT MANUFACTURING OR QUALITY BUT, RATHER, IS AN EXCELLENT EXAMPLE OF THE LIMITATION OF CURRENT ENDOVASCULAR TECHNOLOGY HAS IN TREATING HEAVILY DISEASED SUPERFICIAL FEMORAL ARTERIES. THIS MEDWATCH REPRESENTS ONE OF THE THREE PRODUCTS IMPLANTED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR. REPORT #S 9616099-2010-00785, 9616099-2010-00852, AND 9616099-2010-00853.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP, APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE, A POSSIBLE STENT FRACTURE WAS DISCOVERED IN AN UNKNOWN SIZE SMART CONTROL STENT IN THE LEFT SFA. THE IMPLANTING PHYSICIAN IS NOT 100% SURE, THE STENT IS FRACTURED; THEY FEEL IT IS POSSIBLE THE STENT MAY BE SIMPLY BUNCHED UP. THE STENT IS IN THE LEFT SFA, WHICH WAS 90% STENOSED PRIOR TO STENT IMPLANTATION. THE STENT WAS PLACED AFTER A SUBOPTIMAL RESULT WITH A COMPETITOR PTA BALLOON THAT CAUSED A DISSECTION. THE PHYSICIAN DECIDED TO STENT (KNOWING THE SMART STENT WAS OFF-LABEL) BASED ON THE MERITS OF THE PRODUCT. HE CHOSE TO USE THE SMART CONTROL TO TACK UP THE DISSECTION FOLLOWING THE SUBOPTIMAL BALLOON ANGIOPLASTY. THERE WAS NO SEPARATION OR MIGRATION OF THE POSSIBLE FRACTURE, BUT THE STENTED SEGMENTED OF THE VESSEL HAD OCCLUDED AND THROMBOSED, RESULTING IN FLOW LIMITATION. THE PHYSICIAN FEELS THAT THE CULPRIT WAS OUTFLOW DISEASE AND FIBROTIC RESTENOSIS AT THE PROXIMAL EDGE OF THE STENTED SEGMENT. THE PHYSICIAN DID NOT FEEL THAT THE POSSIBLE FRACTURE WAS THE CAUSE OF THE OCCLUDED STENT. THE FRACTURE WAS TREATED WITH MECHANICAL THROMBECTOMY AND RE-STENTING. FLOW WAS RESTORED AND THE PATIENT WAS SENT HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R