BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2862935 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07751
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. ADD'L DEVICES: GUIDE WIRE: SION; INFLATION: ABBOTT 20/30; GUIDE CATH: EBU 3 SH 6F; RHV: COPILOT; SHEATH: TERUMO 6F. 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, DISTAL CIRCUMFLEX ARTERY, THE NON-ABBOTT GUIDE WIRE WAS POSITIONED AND PRE-DILATATION COMPLETED USING A NON-ABBOTT BALLOON DILATATION CATHETER (BDC). A 3.5 X 15 MM MULTI-LINK VISION STENT WAS SUCCESSFULLY IMPLANTED. A 3.5 X 8 MM VOYAGER NC BDC WAS ADVANCED BUT COULD NOT CROSS THE IMPLANTED VISION STENT; IT WAS ALSO NOTED THAT ANATOMICAL RESISTANCE WAS FELT AND AFTER REMOVAL THAT THERE WAS A KINK IN THE PROXIMAL EDGE OF THE DEVICE HYPOTUBE. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 15 MM VOYAGER NC BDC. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT INFORMATION RECEIVED FROM THE SITE REPORTED THAT THE 3.5 X 15 MM VISION STENT WAS NOTED NOT TO BE FULLY OPPOSED TO THE VESSEL WALL REQUIRING POST-DILATATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention