BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3884985 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03963
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR STENT DISLODGMENT REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE MULTI-LINK 8 CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND THE 4.0 X 23 MM MULTI-LINK 8 STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, AFTER THE SDS BALLOON WAS INFLATED, IT WAS SEEN ON IMAGING THAT THE STENT WAS NOT IMPLANTED. IT WAS THEN FOUND THAT THE STENT HAD DISLODGED IN THE PROTECTIVE SHEATH, PRIOR TO BEING INSERTED INTO THE VESSEL. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE SHEATH. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361989 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3070841

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR