BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 107260 · Received July 21, 1997

    Report

    Report Number
    2247023-1997-00217
    Event Type
    Death
    Date Received
    July 21, 1997
    Date of Event
    May 15, 1997
    Report Date
    July 1, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED SINCE ADDITIONAL INFO HAS BEEN RECEIVED AFTER REVIEWING THE PT'S MEDICAL RECORDDS ON 7/7/1997. CORDIS IS CURRENTLY ATTEMPTIG TO PROCURE THE PRODUCT UPON WHICH THIS REPORT IS BASED FOR EVALUATION. SHOULD THE PRODUCT BECOME AVAILABLE, A FOLLOW-UP 3500A REPORT WILL BE SUMBITTED TO INCLUDE THE EVALUATION RESULTS. THE FOLLOWING ADDITIONAL INFO RELATIVE TO THE DETAILS OF THIS EVENT WERE RECEIVED ON 10/7/1997: PRIOR TO ATTEMPTING TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PTS LEFT ANTERIOR DESCENDING ARTERY, THE LESION WAS PREDILATED. FOLLOWING PREDILATATION, IT WAS REPORTED THAT THE LAD WAS OPENED WITH SMALL DISSECTION AND SOME HAZINESS NOTED IN THE PROXIMAL LAD. SUBSEQUENTLY, A CORONARY STENT WITH DELIVERY SYSTEM WAS SUCCESSFULLY ADVANCED AND DEPLOYED IN THE PROXIMAL LAD. THE STENT WAS POST DILATED WITH AN NC BANDIT BALLOON CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON WAS MOVED SLIGHTLY DISTAL AND DILATED AGAIN AND THEN THE BALLOON WAS REMOVED. SUBSEQUENTLY, SOME DISTAL LAD SPASM WHICH CAUSED SOME CLOT AND THOMBUS IN THE MID LAD WAS REPORTED. IN RESPONSE, ANOTHER BALLOON CATHETER WAS INTRODUCED AND ADVANCED TO THE AREA OF THE MID LAD AND WAS DILATED. THE THROMBUS WAS REPORTED AS BEING "BETTER, BUT IT DID NOT GO AWAY." THE PTS WAS GIVEN SEVERAL REPEATED DOSES OF INTRACORONARY NITRO FOR SPASM AND THE THROMBUS. SUBSEQUENTLY, REOPRO INFUSION WAS STARTED. IT WAS REPORTED THAT AT THE TIME THE PT LEFT THE CATH LAB, EVERYTHING LOOKED WIDE OPEN WIHTH GOOD BRISK FLOW. THERE WAS SOME RESIDUEAL THROBMUS NOTED IN THE MID LAD. THE PT WAS PUT ON A REOPR DRIP AND GIVEN LOW DOSE HEPARIN. LATER THAT EVENING, IT WAS REPORTED THAT THE PT WAS NAUSEATED AND HAD CHEST PAIN AND THREW UP ONE TIME. THE PT ALSO HAD A CARDIAC ARREST. THE PT HAD NO RESPONSE TO ACLS TREATMENT AFTER THIRTY-FIVE MINUTES AND WAS PRONOUNCED DEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY A CORONARY STENT WITH DELIVERY SYSTEM ON 5/15/97, TO AN UNSPECIFIED TARGET LESION SITE PT'S BOYD, THE "STENT SEVERED AN ARTERY". AS A RESULT, IT WAS REPORTED THAT THE SEVERED ARTERY HEMORRHAGED FOR SEVERAL HOURS CAUSING THE EVENTUAL DEATH OF THE PT ON 5/16/97.

    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 JD0782

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death