BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 2193533 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05564
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE MULTI-LINK 8 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, COULD NOT 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 THAT ON (B)(6) 2011 DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, A 3.5 X 28 MULTILINK 8 WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED AS FINE AND STABLE. ON (B)(6) 2011, THE PATIENT COMPLAINED OF CHEST PAIN. REPEAT ANGIOGRAPHY REVEALED INSTENT RESTENOSIS. BALLOON ANGIOPLASTY WAS PERFORMED; HOWEVER, THE PHYSICIAN STATED AN ADDITIONAL STENT WILL NEED TO BE IMPLANTED FOR TREATMENT OF THE RESTENOSIS. REPORTEDLY, THE PATIENT CANNOT FINANCIALLY AFFORD A DRUG ELUTING STENT; THEREFORE, RE-INTERVENTION IS UNDETERMINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0031041

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R