BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 3903344 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04230
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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). INTERNAL FILE NUMBER - 250933/1-1 EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. THE REPORTED DIFFICULTY POSITIONING WITH THE GUIDE CATHETER COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE ANALYSIS OF THE 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 THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULTY POSITIONING WITH THE GUIDE CATHETER OR STENT DISLODGEMENT REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RIGHT CORONARY ARTERY. A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE LESION AND A 4.5 X 18 MM ULTRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE GUIDE WIRE; HOWEVER, WHEN THE SDS ENTERED THE GUIDING CATHETER, THE STENT DISLODGED. THE DEVICES WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 4.0 X 15 MM NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379573 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 4012941

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR GUIDE WIRE: LUGE