BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 163219 · Received April 15, 1998

    Report

    Report Number
    2247023-1998-00048
    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 FOLLOWING INFO WAS REPORTED BY THE PT THROUGH RECEIPT OF HIS MEDICAL RECORDS: ON 5/21/1996 THIS PT WAS ADMITTED TO THE CATH LAB FOR PTCA AND STENTING. THREE STENTS WERE SUCCESSFULLY DEPLOYED IN THE PT'S RIGHT CORONARY ARTERY: THE FIRST ONE AT A SITE JUST DISTAL TO THE MID RIGHT CORONARY ARTERY, A SECOND STENT AT THE MID RIGHT CORONARY ARTERY AND THE LAST STENT WAS PLACED JUST DISTAL TO THE FIRST STENT. THE LAST STENT WAS PLACED ONLY IN RESPONSE TO A LINEAR DISSECTION WHICH OCCURRED IN CONJUNCTION WITH AGGRESSIVE POST-DILITATION OF THE TWO PREVIOUSLY IMPLANTED STENTS. THE PT SUBSEQUENTLY EXPERIENCED A PERIPROCEDURAL MYOCARDIAL INFARCTION (MI) AND WAS RETURNED TO THE CATH LAB ON 5/22/1996. ANGIOGRAPHY REVEALED THAT THE CAUSE OF THE MYOCARDIAL INFARCTION WAS AN OCCLUSION OF A MARGINAL BRANCH. ADDITIONALLY, ANGIOGRAPHY REVEALED A "HAZINESS" WITHOUT FLOW LIMITATION IN THE MOST PROXIMAL STENT. THE PHYSICIAN INTERPRETED THE HAZINESS TO BE A POSSIBLE SUBACUTE STENT THROMBOSIS AND, IN RESPONSE, HE RE-PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY'D THE PROXIMAL STENT. THE PT WAS TRANSFERRED FROM THE CATH LAB WITH ALL STENTS PATENT AND IN STABLE CONDITION.

    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 JD0817

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention CATH, 8 F FEMORAL SHEATH.| .014 X 300 GUIDE WIRE, 5F 4CM LEFT JUDKINS GUIDE