BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON & JOHNSON CORDIS

    MDR report key: 208743 · Received December 11, 1997

    Report

    Report Number
    208743
    Event Type
    Injury
    Date Received
    December 11, 1997
    Date of Event
    October 8, 1997
    Report Date
    October 21, 1997
    Manufacturer
    *
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFLATED 3/5/ JJ STENT AND BALLOON AT 7 ATM. PIN HOLE RUPTURE CAUSED DISECTION PROXIMAL TO STENT AND MD INSERTED 4/0JJ STENT PROXIMAL TO FIRST STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON CORDIS Implant CORONARY STENT MAF * PS1535 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention