BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2191536 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00782
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    March 14, 2013
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (MYOCARDIAL INFARCTION, DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, CONCLUSIONS: GI BLEED, TVR.

    Description of Event or Problem · 1

    APPROXIMATELY 46 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A MI. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. APPROXIMATELY 48 MONTHS POST INDEX PROCEDURE THE PATIENT DIED. CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVASCULARIZATION EVENT PREVIOUSLY REPORTED OCCURRED 17.5 MONTHS POST INDEX PROCEDURE AND NOT 7.5 MONTHS POST INDEX PROCEDURE. IT WAS ASSESSED BY THE INVESTIGATOR THAT THIS EVENT WAS NOT RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    DURING THE PREVIOUSLY REPORTED GI BLEED, THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE INVESTIGATOR HAS ASSESSED THAT THE PATIENT RECOVERED FOLLOWING THE PREVIOUSLY REPORTED TARGET VESSEL REVASCULARIZATION THAT OCCURRED APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE. ON THE SAME DAY AS THE PREVIOUSLY REPORTED MI, THE PATIENT HAD A REVASCULARIZATION OF THE LAD USING A RESOLUTE INTEGRITY DRUG ELUTING STENT. CAUSE OF DEATH WAS CARDIOPULMONARY ARREST.

    Description of Event or Problem · 1

    PATIENT DEATH ALSO DUE TO CAD, SEPSIS AND COPD. PATIENT DEATH WAS NOT ASSESSED FOR RELATEDNESS WITH THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL RCA AND ONE ENDEAVOR SPRINT RX STENT IMPLANTED IN THE RIGHT POSTEROLATERAL. APPROX 7.5 MONTHS POST INDEX PROCEDURE THE PT EXPERIENCED CHEST PAIN. A REVASCULARIZATION WAS CARRIED OUT TO THE DISTAL LAD, SVG TO MID RCA AND SVG TO DISTAL RCA. THREE OTHER BRAND STENTS WERE IMPLANTED. APPROX 8 MONTHS POST INDEX PROCEDURE THE PT WAS READMITTED WITH CHEST PAIN, THE PT HAD PTCA OF THE 2ND OBTUSE MARGINAL, THE MID LCX AND THE LEFT MAIN, WITH 3 OTHER BRAND STENTS IMPLANTED. APPROX 10.5 MONTHS POST INDEX PROCEDURE THE PT EXPERIENCED FURTHER CHEST PAIN AND SHORTNESS OF BREATH AND ONE OTHER BRAND STENT WAS IMPLANTED IN THE MID LAD. THE INVESTIGATOR HAS INDICATED THAT THE EVENTS WERE NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. APPROX 25 MONTHS POST INDEX PROCEDURE IT IS REPORTED THAT THE PT SUFFERED A GI BLEED. THE PT WAS TREATED WITH 4 UNITS OF PACKED RED BLOOD CELLS. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE OR THE STUDY PROCEDURE. PT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF MFR # 9612164-2011-00781).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R ASPIRIN| CLOPIDOGREL