BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2993387 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01335
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II. GUIDE CATHETER: 5 FRENCH JCL 3.5 LAUNCHER. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A 5 FRENCH NON-ABBOTT GUIDE CATHETER AND A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE TO THE TARGET SITE. A 2.5 X 12 MM TREK DILATATION CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED TO 8 ATMOSPHERES TO PERFORM PRE-DILATATION. THE BALLOON WAS DEFLATED AND THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY. A 2.5 X 15 MM MINI VISION STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE TARGET SITE. RESISTANCE WAS FELT AND THE DEVICE WAS NOT ABLE TO CROSS TO THE TARGET LESION. THE PHYSICIAN BEGAN TO WITHDRAW THE STENT DELIVERY SYSTEM. IT WAS NOTED THAT THE MINI VISION STENT DISLODGED FROM THE STENT DELIVERY SYSTEM; HOWEVER, IT WAS NOT KNOWN IF THE STENT DISLODGED DURING ADVANCEMENT OR DURING WITHDRAWAL OF THE DEVICE. THE PHYSICIAN THEN WITHDREW THE ENTIRE SYSTEM IN AN ATTEMPT TO REMOVE THE DISLODGED STENT; HOWEVER, THE STENT DISLODGED IN THE ULNAR ARTERY. A 2.0 MICROSNARE DEVICE WAS ADVANCED AND WAS ABLE TO RETRIEVE THE DISLODGED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA; HOWEVER, A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB THE NEXT DAY. A NON-ABBOTT ATHERECTOMY DEVICE WAS ADVANCED INTO THE PATIENT ANATOMY, BUT WAS UNABLE TO CROSS TO THE TARGET SITE AND WAS REMOVED. THE PHYSICIAN ENDED THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97640 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention