BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 2112112 · Received June 2, 2011

    Report

    Report Number
    2024168-2011-03856
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    October 12, 2010
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MAUDE REPORT ((B)(4)) THAT THE PATIENT HAS HAD MULTIPLE PERCUTANEOUS CORONARY INTERVENTIONS. THE MOST RECENT WAS FOR PLACEMENT OF A NON-ABBOTT STENT IN THE MID CIRCUMFLEX IN 2009. ON (B)(6) 2010, THE PATIENT ARRIVED IN THE EMERGENCY ROOM WITH A STEMI, AND HAD APPARENTLY BEEN OFF HIS ASA AND PLAVIX FOR 1-2 WEEKS. FILMS REVEAL THE MID CIRCUMFLEX WITH A 90% THROMBOTIC OCCLUSION, ALSO THE OBTUSE MARGINAL 1 WITH A 90% THROMBOTIC OCCLUSION OF A 3.0 X 23 MM MULTI-LINK VISION STENT PLACED (B)(6) 2008. THROMBECTOMY WAS PERFORMED WITH MINIMAL RESULTS DUE TO DIFFICULTY CROSSING THE STENTED AREAS COMPLETELY WITH THROMBECTOMY CATHETER. A 3.0 X 15 NC QUANTUM APEX, 2.5 X 15 NC QUANTUM APEX, AND 2.0 X 15 APEX WERE USED TO DILATE THE LESIONS. FINAL FILMS REVEAL GOOD ANGIOGRAPHIC RESULTS AND IT WAS DECIDED TO STOP AT THE POINT WITH ANGIOPLASTY ALONE. THE PATIENT WAS DISCHARGED ON ASA AND EFFIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 8041631

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R