BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 2032882 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02126
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX ULTRA STENT DELIVERY SYSTEM (SDS) NOTED ONLY THE STENT IMPLANT, PROTECTIVE SHEATH, AND STYLET WERE RETURNED. THE SDS WAS NOT RETURNED. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT, PROTECTIVE SHEATH, OR STYLET. THE INNER DIAMETER OF THE FLARED END OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT OUTER DIAMETER DIMENSION WAS OVERSIZED; HOWEVER, BECAUSE STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WITHIN THE REQUIRED SPECIFICATION, THIS OVERSIZING MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT, AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON SHOULDERS. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. RETURN OF THE CATHETER OF THE SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT DISLODGMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. DATE OF EVENT WAS ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE HOOP FOR USE, AFTER SHEATH REMOVAL, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0080541

    Patients

    Seq Age Sex Outcome Treatment
    1