BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK 8

    MDR report key: 1888781 · Received October 19, 2010

    Report

    Report Number
    2024168-2010-02197
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECT OF DEATH, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT 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. THE 2.75 X 38 MM MULTI LINK 8 (PART 1012166-38, LOT 9122361), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS A (B)(6) MALE THAT PRESENT TO THE CATH LAB IN RESPIRATORY DISTRESS, ACUTE CORONARY SYNDROME, EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION AND WAS IN CARDIOGENIC SHOCK. THE LESION WAS IN THE (RCA) AND THE DECISION WAS MADE TO IMPLANT 2 MULTI-LINK 8 STENTS FOR TREATMENT. THE PERCUTANEOUS CORONARY INTERVENTION WAS SUCCESSFUL WITH A GOOD RESULT; HOWEVER, THE PT'S CONDITION DETERIORATED WITH THE HOUR AFTER THE END OF THE PROCEDURE, RESULTING IN THE PT'S DEATH. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9120461

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death STENT: 2.75 X 38 MM MULTI LINK 8| (PART 1012166-38, LOT 9122361)