BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1884090 · Received October 21, 2010

    Report

    Report Number
    2953200-2010-02016
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    August 23, 2011
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (CVA/STROKE).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (REVASCULARIZATION).

    Description of Event or Problem · 1

    FOUR ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE IMPLANTED, TWO AT THE MID LAD AND TWO AT THE PROXIMAL LAD. IN STENT RESTENOSIS IS REPORTED APPROX 4.5 MONTHS FOLLOWING INDEX PROCEDURE. A PCI REVASCULARIZATION WAS CARRIED OUT, WHERE TWO OTHER BRAND STENTS WERE IMPLANTED IN THE MID LAD. ONE DAY LATER, THE PT SUFFERED A SPONTANEOUS INTRACRANIAL HEMORRHAGE. PT WAS DIAGNOSED WITH INTERCRANIAL BLEED BY CAT SCAN. PT REQUIRED PLATELETS AND A PRBC TRANSFUSION OF 4 UNITS WAS CARRIED OUT. INVESTIGATOR INDICATED THAT THERE WAS NO RELATIONSHIP TO THE STUDY DEVICE. IT WAS REPORTED THAT PT RECOVERED WITH TREATMENT (REF: MFR REPORTS 2953200-2010-00358, 2953200-2010-00359 AND 2953200-2010-02017).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT HAD A REVASCULARIZATION AND WAS SENT FOR CABG. IT IS NOT INDICATED THAT THE TARGET VESSEL WAS INVOLVED. PATIENT IS REPORTED TO BE RECOVERED WITH TREATMENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF: MFR REPORTS 2953200-2010-00358, 2953200-2010-00359 2953200-2010-02016 AND 2953200-2010-02017).

    Description of Event or Problem · 1

    THE INVESTIGATOR HAS INDICATED THAT THE REVASCULARIZATIONS CARRIED OUT APPROXIMATELY 4.5 MONTHS AND 2 YEARS POST THE INDEX PROCEDURE WERE PROBABLY RELATED TO THE STUDY DEVICE AND THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    THE LIMA TO LAD WAS TREATED DURING THE PREVIOUSLY REPORTED CABG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention