BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3061363 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02318
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGAINST RESISTANCE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE VIA FEMORAL ACCESS IN THE HEAVILY CALCIFIED/TORTUOUS PROXIMAL-MID RIGHT CORONARY ARTERY (RCA), PRE-DILATATION WAS PERFORMED USING A 1.5X12 MINI TREK BALLOON. AN ATTEMPT WAS MADE TO ADVANCE A 2.0X15 RX MINI VISION STENT DELIVERY SYSTEM. RESISTANCE WAS FELT DUE TO THE ANATOMY AND THE PHYSICIAN MADE NUMEROUS ATTEMPTS TO ADVANCE THE DEVICE BY PULLING BACK AND ADVANCING THE STENT SYSTEM FORWARD WITHOUT USING FORCE. DURING ONE OF THE ATTEMPTS TO PULL BACK ON THE STENT SYSTEM WITHOUT RESISTANCE, THE STENT DISLODGED FROM THE BALLOON. RETRIEVAL ATTEMPTS USING A SNARE WERE UNSUCCESSFUL; THEREFORE, THE STENT WAS CRUSHED AGAINST THE VESSEL WALL. A 2.0X12 RX MINI VISION STENT DELIVERY SYSTEM WAS ADVANCED IN AN ATTEMPT TO DEPLOY THE STENT OVER THE CRUSHED STENT; HOWEVER, THE STENT SYSTEM COULD NOT ADVANCE TO THE TARGET SITE IN THE RCA DUE TO THE CHARACTERISTICS OF THE VESSEL AND THE EMBEDDED STENT. THE STENT SYSTEM WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE AND IT WAS NOTED THAT SEVERAL STENT STRUTS WERE FLARED. ADDITIONAL DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON AND A NON-ABBOTT BARE METAL STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET SITE IN THE RCA. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163397 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2073141

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention GUIDE CATHETER: 6F