BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 119423 · Received September 11, 1997

    Report

    Report Number
    2247023-1997-00282
    Event Type
    Death
    Date Received
    September 11, 1997
    Date of Event
    July 24, 1997
    Report Date
    July 28, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAPH AUREUS PT CATHED AT OUTSIDE HOSP AND SENT HERE FOR PTCA & STENT PLACEMENT OF THE RCA ON 4/1/97. RETURNED TO OUTSIDE HOSP & DISCHARGED HOME IN 2 DAYS. PT FELT BAD ON THE WAY HOME, HAD FEVER & STOPPED AT ANOTHER FACILITY. BLOOD CULTURES WERE + FOR STAPH AUREUS. PT SENT TO ANOTHER FACILITY WHERE A CARDIAC CATH REVEALED MYCOTIC ANUERYSM AT THE RCA STENT SITE & VEGETATION ON THE AORTIC VALVE WITH AORTIC INSUFFICIENCY. PT SENT BACK TO OUTSIDE HOSP FOR FURTHER ANTIBIOTIC MANAGEMENT & THEN RETURNED TO THIS FACILITY FOR CV SURGERY. PRIOR TO SURGERY, PT HAD DEVELOPED RENAL INSUFFICIENCY FROM ANTIBIOTIC THERAPY. HAD CAB & AVR; WENT INTO RENAL FAILURE & HAD TO BE PLACED ON DIALYSIS; HAD DECREASED MENTAL STATUS. CONTINUED TO HAVE DIFFICULT POSTOP COURSE WITH MULTI SYSTEM ORGAN FAILURE AND DIED ON 7/24/97.

    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 NEW JERSEY PLANT NA JB1761

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death