BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO .035 SELF EXPLANING STENT SYSTEM

    MDR report key: 1161547 · Received September 15, 2008

    Report

    Report Number
    3004742046-2008-00212
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MAF
    PMA / PMN Number
    072708
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ABSOLUTE PRO WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INNER MEMBER. ALTHOUGH IT WAS REPORTED THAT THE UNEXPANDED STENT HAD DISLODGED FROM THE DELIVERY CATHETER, THE RETURNED STENT WAS MOVED DISTAL TO THE SHEATH. THE DISTAL END WAS FLARED. THE PROXIMAL END OF THE STENT WAS MOVED DISTAL FROM THE PROXIMAL MARKER. THE HANDLE WAS OPENED TO REVEAL THE RACK WAS IN THE DISTAL END. THERE WAS NO DAMAGE NOTED TO THE ABSOLUTE PRO. IT IS POSSIBLE FOR THE STENT TO BE MOVED DISTAL DURING PRODUCTION OR USE IN THE FIELD, ALTHOUGH PRODUCT HAS SEVERAL 100% INSPECTIONS TO VERIFY THAT THE STENT ALIGNMENT IS BETWEEN THE MARKERS AND THAT THE DISTAL SHEATH COMPLETELY COVERS THE STENT. THE STENT COULD ALSO MOVE FORWARD IF THE DISTAL END IS PULLED DURING REMOVAL OF THE STYLET. IT IS POSSIBLE THAT, IN THE FIELD, WHEN THE STYLET WAS WITHDRAWN, BOTH THE TIP AND STYLET WERE PULLED TOGETHER, WHICH WOULD PULL THE STENT DISTALLY. ENGINEERING HAS REPLICATED THE SAME FAILURE MODE. REVIEW OF THE DEVICE LOT HISTORY RECORD FOUND NO NON-CONFORMITIES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. A ROOT CAUSE OF THE DISTAL END OF THE STENT BEING EXPOSED COULD NOT BE DETERMINED, BASED ON THE INVESTIGATION FINDING.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DISLODGEMENT. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: IT WAS REPORTED THAT DURING DEVICE PREPARATION, OUTSIDE OF THE BODY, THE ABSOLUTE PRO UNEXPANDED STENT COME COMPLETELY OFF OF THE CATHETER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPLANING STENT SYSTEM NONE MAF ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8060951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK