BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ENDEAVOR STENT

    MDR report key: 1031657 · Received April 17, 2008

    Report

    Report Number
    MW5006328
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 6, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASED ON STRESS TEST RESULTS, PT NEEDS HEART CATH. PATIENT TAKING ASPIRIN, BETABLOCKER AND STATIN. CATHETER DONE WITH 70% BLOCKAGE OF AEC-80% OF OM. TREATMENT PLAN IS TO PUT A STENT IN 2ND OM AND 1 STENT IN MID CIRC. SUCCESSFUL WITH NO COMPLICATIONS AND EXCELLENT RESULTS. MEDS GIVEN DURING PROCEDURE WERE NSE100ML/HR - 2MG VERSED - 2% LIDOCAINE (NUMBGROIN) ANGIOMAX 15ML BOLUS- ANGIOMAX - 35ML HR - IC NITRO TOTAL 400MC.-PLAVIX 600MG - FENTANYL - 25 MEG - 30ML MAALOX - .400MG NITROL SL. PT RETURNED TO ROOM WHERE HE CODED. PATIENT TAKEN EMERGENTLY BACK TO CATH LAB, AND FOUND 100% MID LOX BETWEEN THE 2 STENTS, AND ALSO COMPLETE OCCLUSION OF THE DISTAL STENT. IN ADDITION, THERE WAS SOME CLOT IN THE OM2 BRANCH THAT HAD NOT UNDERGONE INTERVENTION IN PRIOR PROCEDURE. BALLOON, STENTED THIS SITE GOOD RESULTS, BUT OM2 AND DISTAL LCX BOTH CLOSED OFF. PTCA TO OM2 AND PTCA AND STENT TO LCX. GOOD FLOW WAS NOTED POST CATH. ANOXIC BRAIN INJURY APPEARS TO HAVE INCURRED DURING CODE BLUE.

    Description of Event or Problem · 1

    BASED ON STRESS TEST RESULTS PT NEEDS HEART CATH. PATIENT TAKING ASPIRIN, BETABLOCKER AND STATIN. CATHETER DONE WITH 70% BLOCKAGE OF AEC-80% OF OM. TREATMENT PLAN IS TO PUT A STENT IN 2ND OM AND 1 STENT IN MID CIRC. SUCCESSFUL WITH NO COMPLICATIONS AND EXCELLENT RESULTS. MEDS GIVEN DURING PROCEDURE WERE NSE100ML/HR - 2MG VERSED - 2% LIDOCAINE (NUMBGROIN) ANGIOMAX 15ML BOLUS- ANGIOMAX - 35ML HR - IC NITRO TOTAL 400MC.-PLAVIX 600MG - FENTANYL - 25 MEG - 30ML MAALOX - .400MG NITROL SL. PT RETURNED TO ROOM WHERE HE CODED. PATIENT TAKEN EMERGENTLY BACK TO CATH LOB AND FOUND 100% MID LOX BETWEEN THE 2 STENTS AND ALSO COMPLETE OCCLUSION OF THE DISTAL STENT. IN ADDITION, THERE WAS SOME CLOT IN THE OM2 BRANCH THAT HAD NOT UNDERGONE INTERVENTION IN PRIOR PROCEDURE. BALLOON, STENTED THIS SITE GOOD RESULTS, BUT OM2 AND DISTAL LCX BOTH CLOSED OFF. PTCA TO OM2 AND PTCA AND STENT TO LCX. GOOD FLOW WAS NOTED POST CATH. ANOXIC BRAIN INJURY APPEARS TO HAVE INCURRED DURING CODE BLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ENDEAVOR STENT ENDEAVOR DRUG ELUTING STENT NIQ MEDTRONIC VASCULAR EN 25012 0000590383
    2 MEDTRONIC ENDEAVOR STENT ENDEAVOR DRUG ELUTING STENT NIQ MEDTRONIC VASCULAR EN30015MX 0000597584

    Patients

    Seq Age Sex Outcome Treatment
    1