BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 163228 · Received April 15, 1998

    Report

    Report Number
    2247023-1998-00047
    Event Type
    Injury
    Date Received
    April 15, 1998
    Date of Event
    May 24, 1996
    Report Date
    April 2, 1998
    Manufacturer
    CORDIS, A JOHNSON AND JOHNSON CO
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THE FOLLOWING INFO BY WAY OF HIS MEDICAL RECORDS: ON 5/21/1996 THREE STENTS HAD BEEN SUCCESSFULLY IMPLANTED IN THE PT'S RIGHT CORONARY ARTERY: ONE IN THE MID-RIGHT CORONARY ARTERY, ONE STENT IN THE REGION JUST DISTAL TO THE MID-RIGHT CORONARY ARTERY AND ONE AT A SITE MORE DISTAL BUT ALSO WITHIN THE RIGHT CORONARY ARTERY. AT SOME TIME BETWEEN 5/21 AND 5/22, THE PT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION AND WAS BROUGHT BACK TO THE CARDIAC CATH LAB. ANGIOGRAPHY REVEALED THAT THE MYOCARDIAL INFARCTION HAD BEEN CAUSED BY AN OCCLUSION OF THE MARGINAL BRANCH. DURING ADDITIONAL INTERVENTIONAL PROCEDURES, A PROXIMAL RIGHT CORONARY ARTERY SPASM AND STENOSIS WERE NOTED. IN RESPONSE, THIS STENT WAS SUCCESSFULLY DEPLOYED IN THE MOST PROXIMAL RIGHT CORONARY ARTERY. ON 5/24, THE PT PRESENTED WITH ATYPICAL CHEST PAIN AND WAS AGAIN RETURNED TO THE CATH LAB. ANGIOGRAPHY REVEALED A LARGE MOBILE THROMBOTIC ELEMENT IN THE MOST PROXIMAL RIGHT CORONARY ARTERY. IN RESPONSE THE PT WAS SENT TO THE OR FOR CORONARY REVASCULARIZATION OF THE RIGHT CORONARY ARTERY. THE PT WAS DISCHARGED IN STABLE CONDITION TO HOME ON POST-OP DAY 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF CORDIS, A JOHNSON AND JOHNSON CO NA 100113

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention CATHETER.| .014 X 300HTF GUIDEWIRE, ARI RIGHT AMPLATZ GUIDE| CATH, 8 F FEMORAL SHEATH, 4.0 NC BANDIT BALLOON