BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 2840747 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07335
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF EVENT AS THE SURGERY WAS REPORTED TO HAVE OCCURRED THREE WEEKS PRIOR TO (B)(6) 2012. ESTIMATED IMPLANT DATE AS THE MONTH AND YEAR OF IMPLANT WERE PROVIDED, (B)(6) 2012; HOWEVER, THE EXACT DATE IN (B)(6) IS UNKNOWN. 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 BY A PATIENT THAT THE PIXEL STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL IN (B)(6) 2002. ON APPROXIMATELY (B)(6) 2012, THE PATIENT UNDERWENT EMERGENCY OPEN HEART SURGERY. AT THAT TIME THE STENT WAS FOUND TO BE "COMPLETELY COLLAPSED." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention