BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 2192196 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05513
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED ABSOLUTE SELF EXPANDING STENT SYSTEM (SESS) NOTED BLOOD AND SALINE ON THE STENT IMPLANT AND IN THE SHAFT, CONSISTENT WITH THE REPORTED USE. THERE WAS BLOOD ON THE HANDLE. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT BETWEEN THE MARKERS. THE STENT IMPLANT WAS SEPARATED 7.4 CM DISTAL TO THE PROXIMAL END OF THE STENT AS REPORTED. THERE WAS 8 MM OF THE STENT STRUTS PROTRUDING FROM THE DISTAL END OF THE DISTAL SHEATH. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE SEPARATED PORTION OF THE STENT WAS NOT RETURNED. THE OUTER MEMBER WAS SEPARATED AT THE PROXIMAL END OF THE DISTAL SHEATH. THE FRACTURE FACE WAS STRETCHED AND JAGGED, SUGGESTING FORCE HAD BEEN APPLIED. THERE WAS A 7.9 CM GAP BETWEEN THE SEPARATED PORTIONS OF THE OUTER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE HANDLE LOCK WAS IN THE UNLOCKED POSITION. AFTER OPENING THE HANDLE, THE RACK WAS FULLY RETRACTED IN THE PROXIMAL POSITION. THERE WAS NO DAMAGE NOTED INTERNAL MECHANISMS. POTENTIAL FACTORS FOR THE ABSOLUTE PRO FAILING TO DEPLOY AND/OR DIFFICULTY RETRACTING THE THUMBWHEEL INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). IN THIS CASE, BASED ON THE RETURNED DEVICE ANALYSIS, IT MAY BE POSSIBLE THAT THE DISTAL END OF OUTER MEMBER WAS ENTRAPPED WITHIN THE LESION SITE AND/OR ANATOMY PREVENTING THE SHEATH FROM FULLY RETRACTING. FURTHERMORE, AS FORCE WAS APPLIED IN AN ATTEMPT TO FURTHER DEPLOY THE STENT, THE DISTAL OUTER MEMBER SEPARATED, PREVENTING THE REMAINDER OF THE STENT FROM DEPLOYING. ADDITIONALLY, WITH ONLY THE DISTAL END OF THE STENT EXPANDED AND APPOSED TO THE VESSEL WALL, IT IS POSSIBLE THAT DURING WITHDRAWAL OF THE SYSTEM, THE STENT FRACTURED LEAVING THE DISTAL SEGMENT IN THE ANATOMY. AS IT WAS REPORTED THAT FORCE WAS APPLIED AFTER THE UNSUCCESSFUL ATTEMPT TO ROTATE THE THUMBWHEEL, IT SHOULD BE NOTED THAT THE ABSOLUTE PRO INSTRUCTION FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME, INCLUDING RESISTANCE UNLOCKING THE HANDLE OR ROTATING THE THUMBWHEEL, DURING EITHER STRICTURE ACCESS OR STENT DEPLOYMENT, THE ENTIRE SYSTEM SHOULD BE REMOVED TOGETHER WITH THE INTRODUCER SHEATH OR GUIDING CATHETER AS A SINGLE UNIT. FAILURE TO FOLLOW THESE INSTRUCTIONS COULD RESULT IN FAILURE TO DEPLOY, DIFFICULTY WITH DEPLOYMENT AND PARTIAL STENT DEPLOYMENT OR DEPLOYMENT IN AN UNINTENDED LOCATION. ADDITIONALLY, BECAUSE IT WAS REPORTED THAT THE ABSOLUTE PRO WAS USED TO TREAT COMMON ILIAC VESSEL, IT SHOULD ALSO BE NOTED THAT THE INDICATIONS FOR USE IN THE IFU STATES: THE ABSOLUTE .035 BILIARY SELF-EXPANDING STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. DURING PRODUCTION ALL SELF EXPANDING STENTS ARE VISUALLY INSPECTED ON BOTH THE INNER DIAMETERS AND OUTER DIAMETERS FOR DAMAGE. ADDITIONALLY, THE STENTS ARE INSPECTED AFTER THE STENT HAS BEEN COLLAPSED ONTO THE STENT HOLDER. ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE ALSO INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. REPORTED THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE DISTAL COMMON ILIAC VESSEL, THE ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) WAS POSITIONED AT THE TARGET LESION AND THE THUMBWHEEL WAS BEING TURNED TO DEPLOY THE STENT. THE THUMBWHEEL FROZE/STOPPED AND THE STENT WAS PARTIALLY DEPLOYED. FORCE WAS APPLIED TO THE THUMBWHEEL IN AN ATTEMPT TO SALVAGE THE PARTIALLY DEPLOYED STENT, HOWEVER, IT FRACTURED AND SEPARATED INTO TWO PIECES AND APPROXIMATELY 40-50MM OF STENT REMAINED IN THE VESSEL. THE SDS AND PART OF THE STENT WAS REMOVED FROM THE ANATOMY. AN OMNILINK SDS WAS USED TO EXPAND AND SECURE THE FRACTURED STENT AND TREAT THE LESION WITHOUT INCIDENT. ALTHOUGH A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED DUE TO THE DEVICE ISSUE, NO ADDITIONAL MEDICATION WAS GIVEN AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0082461

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention