BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3182611 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03861
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED PRODUCT MIX-UP WAS CONFIRMED. THE 3.5 X 28 MM RX VISION (B)(4)/LOT 1051141 NOTED THAT THE LOT WAS MANUFACTURED ON 11-MAY-2011 WHEREAS THE 3.5 X 23 MM RX VISION (B)(4)/LOT 2080841 WAS MANUFACTURED 8-AUGUST-2012, APPROXIMATELY 15 MONTHS APART WITH NO RE-WORK INVOLVED; THEREFORE, CONCLUDING THAT THE LOTS WOULD NOT HAVE COME INTO CONTACT WITH ONE ANOTHER DURING PRODUCTION. FURTHER REVIEW OF THE SHIPMENT RECORDS VERIFIED THAT THE HOSPITAL RECEIVED BOTH DEVICES. 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 THESE LOTS. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THESE LOTS DID NOT INDICATE A MANUFACTURING ISSUE. 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 PROXIMAL RIGHT CORONARY ARTERY, THE 3.5 X 23 MM VISION STENT WAS ADVANCED TO THE LESION AND NOTED UNDER FLUOROSCOPY TO BE LONGER THAN EXPECTED; REVIEW OF THE POUCH NOTED THE STENT WAS A 3.5 X 28 MM VISION. THE STENT WAS DEPLOYED WITHOUT ISSUE. ADDITIONALLY, THE VESSEL/LESION LENGTH WAS NOTED TO HAVE BEEN CLOSER TO 25 MM AND THE IMPLANT STENT COVERED THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282694 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1051141

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other