BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1696660 · Received May 21, 2010

    Report

    Report Number
    2953200-2010-00906
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    December 21, 2009
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: STENT THROMBOSIS, DEATH.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN A PT. THE TARGET LESION, LOCATED IN THE LAD # 8 WAS DESCRIBED AS SLIGHTLY TORTUOUS WITH 75% STENOSIS AND WAS PRE-DILATED. DURING PROCEDURE, ONE OTHER ENDEAVOR RX STENT WAS DEPLOYED AT LAD #6 OSTIAL (MFR REPORT # 2953200-2010-00905). COMMUNICATION FROM THE FIELD CONFIRMED THAT SINCE THERE WAS SEVERE CALCIFICATION AT #6, THE PROCEDURE WAS COMPLETED LEAVING 25% OF STENOSIS. HOWEVER, APPROXIMATELY 2 MONTHS POST IMPLANT, HYPOGLYCEMIA BOUTS OCCURRED AND THE PT WAS ADMITTED TO THE HOSPITAL. ONE MONTH LATER, THE PT WAS ADMITTED TO HOSPITAL AGAIN DUE TO HYPOGLYCEMIA BOUTS. IN THIS OCCASION, SYMPTOMS OF CARDIAC FAILURE WERE OBSERVED. IT WAS REPORTED THAT APPROXIMATELY 5.5 MONTHS POST IMPLANT OF RELEVANT STENT, THE PT PRESENTED WITH CHEST PAIN AND WAS EMERGENTLY TRANSFERRED TO HOSPITAL; AS HEALTH CONDITION DETERIORATED, CARDIAC MASSAGE WAS PERFORMED, AND LARYNGEAL TUBE WAS INSERTED. ADRENALINE AND EPINEPHRINE WERE ALSO ADMINISTERED; HOWEVER, THE PT DIED IMMEDIATELY AFTER THESE TREATMENTS. THE PHYSICIAN COMMENTED THAT IT IS HIGHLY LIKELY THAT THE PT DIED DUE TO MULTIPLE FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000968605

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death ASPIRIN| AMALILE| MEVALOTIN| CLOPIDOGREL| ARTIST| NU-LOTAN| BASEN