BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2993200 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01327
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 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
    CA
    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. DATE OF EVENT HAS BEEN ESTIMATED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DISLODGMENT WAS CONFIRMED. BASED ON VISUAL OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 WAS TO TREAT AN UNSPECIFIED VESSEL. DURING ADVANCEMENT OF THE 3.0 X 23 MM VISION STENT DELIVERY SYSTEM (SDS) IT APPEARED ON ANGIOGRAPHY THAT THE STENT IMPLANT HAD DISLODGED FROM THE BALLOON. THE SDS WAS RETRACTED FROM THE PATIENT AND IT WAS CONFIRMED THAT THE STENT IMPLANT WAS NOT ON THE BALLOON. ALTHOUGH A SCAN WAS PERFORMED ON THE ANATOMY AND DID NOT LOCATE THE STENT, IT IS STILL UNDETERMINED IF IT DISLODGED IN THE PATIENT. THE ROOM WAS SEARCHED INCLUDING THE TABLE AND FLOOR; HOWEVER, THE STENT IMPLANT WAS NOT LOCATED. IT WAS CONFIRMED THAT THE STENT IMPLANT WAS ON THE CATHETER PRIOR TO INSERTION IN THE PATIENT. A NEW 3.0 X 23 MM VISION STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED SIGNIFICANT CLINICALLY DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97511 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2053141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other