BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1961539 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00293
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE TIP AND DISTAL OUTER SHEATH, AND ON THE ENTIRE LENGTH OF THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS). THE STENT IMPLANT WAS STATIONARY BETWEEN THE MARKERS AND THE DISTAL OUTER SHEATH WAS NOT RETRACTED. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE PRODUCT WAS INSERTED INTO THE PATIENT ANATOMY BUT NOT DEPLOYED. FAILURE TO DEPLOY CAN BE A RESULT OF, BUT NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). ALTHOUGH THE HANDLE WAS RETURNED IN THE LOCKED POSITION, IT WAS LIKELY LOCKED POST PROCEDURE PRIOR TO SHIPMENT BACK TO ABBOTT VASCULAR. THE HANDLE WAS OPENED AND THE RACK WAS IN THE PROXIMAL PORTION AND FULLY RETRACTED, CONSISTENT WITH THE REPORTED INFORMATION THAT THE THUMBWHEEL WAS ADVANCED AND AN ATTEMPT TO DEPLOY THE STENT WAS MADE. ALL MECHANISMS WERE INTACT WITH NO ANOMALIES NOTED. THE STABILIZER WAS DISSECTED AND REMOVED TO REVEAL THAT THE OUTER MEMBER WAS TORN. THE MATERIAL AT THE TEAR WAS JAGGED, SUGGESTING MATERIAL OVERLOAD (STRESS/FATIGUE). THE INNER BRAIDING WAS STILL INTACT. IN THIS CASE, IT IS POSSIBLE THAT THE DISTAL OUTER SHEATH WAS RETRACTED AGAINST RESISTANCE SUCH THAT AS FURTHER FORCE WAS APPLIED TO THE THUMBWHEEL, THE OUTER MEMBER TORE, WHICH IS CONSISTENT WITH THE FAILURE TO DEPLOY AFTER THE THUMBWHEEL WAS FULLY ROTATED. ALTHOUGH A CAUSE FOR THE RESISTANCE LEADING UP TO THE OUTER MEMBER SEPARATION COULD NOT BE DETERMINED, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. REPORTEDLY, THE ABSOLUTE PRO SESS WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT SHOULD BE NOTED THAT THE ABSOLUTE PRO INSTRUCTIONS FOR USE (IFU) STATES, THE ABSOLUTE PRO .035 BILIARY SELF-EXPANDING STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. THE ABSOLUTE PRO IS NOT INDICATED FOR USE IN THE SFA. IN THIS CASE, IT IS UNKNOWN IF THE OFF LABEL USE OF THE DEVICE CONTRIBUTED TO THE REPORTED FAILURE TO DEPLOY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR FAILURE TO DEPLOY FOR THIS LOT. OVERALL, A CONCLUSIVE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTIES AND SUBSEQUENT DAMAGE COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. DURING PRODUCTION ALL SELF EXPANDING STENTS ARE 100% VISUALLY INSPECTED ON BOTH THE INNER DIAMETERS AND OUTER DIAMETERS FOR DAMAGE. ADDITIONALLY, THE STENTS ARE 100% INSPECTED AFTER THE STENT HAS BEEN COLLAPSED ONTO THE STENT HOLDER. ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE ALSO INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABSOLUTE PRO STENT DID NOT DEPLOY IN THE PRE-DILATED SUPERFICIAL FEMORAL ARTERY AFTER THE THUMBWHEEL WAS DIALED BACK AND THE STENT WAS UNSHEATHED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS. ANOTHER STENT WAS NOT USED. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY ONLY. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE EVALUATION FOUND THAT THE OUTER MEMBER WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 0090761

    Patients

    Seq Age Sex Outcome Treatment
    1