BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 2193632 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05568
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT THE STENT INTERACTED WITH THE CALCIFIED LESION, CONTRIBUTING TO DAMAGING THE STENT RESULTING IN RESISTANCE DURING RETRACTION INTO THE GUIDING CATHETER AND THE STENT ULTIMATELY DISLODGING. THERE WAS NO DAMAGE NOTED TO THE STENT OR STENT DELIVERY SYSTEM DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE DISLODGED STENT EMBOLIZED INTO THE PATIENT ANATOMY AND WAS NOT RETRIEVED. TO HELP ENSURE THE REPORTED DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMANCE MATERIAL RECORD FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE EXTREMELY CALCIFIED, ANGULATED LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), TWO MINIVISION AND ONE VISION STENT DELIVERY SYSTEMS (SDS) WERE UNABLE TO CROSS THE LESION. TWO OTHER MINIVISION AND ONE NON-ABBOTT STENT WERE ABLE TO CROSS AND WERE SUCCESSFULLY IMPLANTED. AN ULTRA SDS WAS UNABLE TO CROSS THE PROXIMAL LAD. DURING REMOVAL, THE SDS MET RESISTANCE ENTERING THE ANGULATED GUIDING CATHETER. ALTHOUGH NO FORCE WAS APPLIED, THE STENT DISLODGED FROM THE SDS IN THE LEFT MAIN CORONARY ARTERY AND FLOATED INTO THE AORTA. AFTERWARDS, THE STENT COULD NOT BE SEEN ON FLUOROSCOPY AND REMAINS IN THE BODY. THE PATIENT WAS ASYMPTOMATIC AND NO INTERVENTION FOR THE DISLODGED STENT WAS PLANNED. THE PROCEDURE WAS COMPLETED AND THE PATIENT LEFT THE CATH LAB IN GOOD CONDITION. 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 1041541

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other STENTS: MINI VISION (X2)INTEGRITY