BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3133382 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03311
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 OR EXCEPTIONS FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATE TO HEAVILY TORTUOUS CIRCUMFLEX (CX). A 2.25X26 MM NON-ABBOTT STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, AFTER DEPOYMENT A DISSECTION WAS OBSERVED DISTAL TO THE STENT. THE FIRST 2.0X15 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO TREAT THE DISSECTION; HOWEVER, BECAME CAUGHT ON THE DEPLOYED STENT. DURING RETRACTION OF THE MINI VISION SDS, THE STENT IMPLANT WAS STILL ATTACHED OT THE EDGE OF THE DEPLOYED STENT CAUSING THE STENT TO DISLODGE FROM THE BALLOON, RESULTING IN THE STENT IMPLANT BECOMING STRETCHED AND ELONGATED. A SNARE DEVICE WAS USED TO SNARE THE DISLODGED STENT SUCCESSFULLY FROM THE ANATOMY. ANOTHER 2.0X15 MM MINI VISION SDS WAS ADVANCED IN AN ATTEMPT AT TREATMENT OF THE DISSECTION; HOWEVER, IT FAILED TO CROSS. A 2.25X8 MM NON-ABBOTT STENT WAS USED TO SEAL THE DISSECTION. THERE WAS ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO ANY ABBOTT DEVICE USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237224 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3020141

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention STENT: 2.25X26 MM RESOLUTE INTEGRITY