BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1891023 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02302
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AS WELL AS CONTRAST IN THE INFLATION LUMEN AND THE BALLOON, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SDS WAS PREPARED FOR USE AND SUGGESTS THAT IT WAS AT LEAST ADVANCED OVER A GUIDE WIRE. THE BALLOON WAS ALSO NOTED TO BE LOOSELY FOLDED, WHICH INDICATES THAT POSITIVE PRESSURE HAD BEEN APPLIED TO THE SYSTEM AT SOME POINT. ALTHOUGH IT IS NOT KNOWN WHEN THIS OCCURRED, FURTHER CLARIFICATION RECEIVED FROM THE ACCOUNT STATED THAT: THERE WAS NO STENT ON THE BALLOON AND THE UNIT WAS NOT USED. IF THE BALLOON WAS INFLATED, IT MAY HAVE BEEN DUE TO A TEST DONE BY THE PHYSICIAN WHEN HE OBSERVED THAT THERE WAS NO STENT BEFORE INSERTION. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ANALYSIS CONFIRMED THAT THE STENT IMPLANT WAS DISLODGED, BUT WAS NOT RETURNED WITH THE SDS FOR ANALYSIS. RETURN OF STENT IMPLANT AND PROTECTIVE SHEATH MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED COMPLAINT. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IN THIS CASE, IT IS POSSIBLE THAT HANDLING OF THE PRODUCT DURING PREPARATION FOR USE CONTRIBUTED TO THE REPORTED DISLODGEMENT; HOWEVER, THIS CANNOT BE VERIFIED. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, AN INCORRECT SIZED SHEATH, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PREPARING THE DEVICE, BEFORE INSERTION IN THE PT, THE PHYSICIAN OBSERVED THAT THERE WAS NO STENT ON THE BALLOON. THE UNIT WAS NOT USED. NO PT INVOLVEMENT WAS REPORTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 0060841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA