BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2832057 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07184
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 22, 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. (B)(4) - AGAINST RESISTANCE . THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS 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. DISSECTION, AS LISTED IN THE RX VISION INSTRUCTIONS FOR USE (IFU) IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE IFU ALSO STATES IN THE WARNING SECTION THAT IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). IT SHOULD BE NOTED THAT THE IFU ALSO STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THE FAILURE TO CROSS THE LESION AND ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 85% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.5 X 28 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS THE LESION. AN ANCHOR BALLOON WAS USED TO INCREASE PUSHABILITY, BUT THE SDS STILL DID NOT CROSS TO THE LESION, AND A DISSECTION OCCURRED IN THE PROXIMAL LAD. A 3.0 X 12 MM VISION STENT WAS USED TO TREAT THE DISSECTION AND A NON-ABBOTT STENT WAS USED TO TREAT THE LESION. THE PATIENT WAS STABLE AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2041141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention