BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 2833741 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07189
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, THROMBOSIS AND STENOSIS ARE LISTED IN THE MULTI-LINK 8 INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. CINE REVIEW CONCLUDED THE IMAGES ARE CONSISTENT WITH ACUTE THROMBOSIS OF A STENT IMPLANT. THE THROMBOSIS APPEARS TO HAVE BEEN TREATED BY THROMBUS EXTRACTION AND BALLOON DILATATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION AT 4:00 PM ON (B)(6) 2012 AND THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-ABBOTT GUIDE WIRE AND A NON-ABBOTT DILATATION CATHETER WERE ADVANCED AND PRE-DILATATION WAS PERFORMED IN THE PROXIMAL LAD ACROSS THE 1ST DIAGONAL. A 2.5X23 RX MULTI-LINK 8 STENT SYSTEM WAS ADVANCED AND IMPLANTED IN THE PROXIMAL LAD ACROSS THE 1ST DIAGONAL. REPORTEDLY, THE PATIENT FELT CHEST PAIN AND WAS MOVED TO THE CARDIAC CARE UNIT TO BE OBSERVED; HOWEVER, STILL FELT CHEST PAIN. AT 9:00 PM ON (B)(6) 2012, ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS. A NON-ABBOTT GUIDE WIRE AND A NON-ABBOTT EXTRACTION CATHETER WERE USED TO REMOVE THE THROMBOSIS IN THE LAD. A 2.5X12 NC TREK RX DILATATION CATHETER WAS USED SUCCESSFULLY FOR POST-DILATATION IN THE LEFT MAIN TRUNK. A HI-TORQUE PILOT 200J GUIDE WIRE, NON-ABBOTT DILATATION CATHETER, AND A 1.2X6 RX MINI TREK DILATATION CATHETER WERE ALL ADVANCED IN AN ATTEMPT TO RESOLVE THE THROMBOSIS IN THE 1ST DIAGONAL; HOWEVER, NONE OF THE DEVICES COULD CROSS THROUGH THE 1ST DIAGONAL AFTER SEVERAL ATTEMPTS. REPORTEDLY, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AS THE PATIENT WAS STABLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY, (B)(6) 2012. DURING THE PROCEDURE, ONLY ONE TUBE OF PROVIS WAS ADMINISTERED VERSUS THE FOUR TUBES IN THE GUIDELINE AND THE PHYSICIAN THOUGHT THAT THIS MAY HAVE BEEN ONE OF THE REASONS CAUSING THE IN-STENT RESTENOSIS BUT COULD NOT CONFIRM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2032341

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention GUIDE WIRE: RUNTHROUGH NS