BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1037110 · Received May 2, 2008

    Report

    Report Number
    2953200-2008-00279
    Event Type
    Injury
    Date Received
    May 2, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MYOCARDIAL INFARCTION. CONCLUSION: LACK OF INFO.

    Description of Event or Problem · 1

    PT HAD A HISTORY OF HYPERTENSION. THREE ENDEAVOR STENTS WERE IMPLANTED IN THE PT ONE MO AGO. ONE ENDEAVOR STENT WAS IMPLANTED IN THE MID-RCA (3.5X30MM STENT) (REF: MDR 2953738-2001-00281). TWO ENDEAVOR STENTS WERE IMPLANTED IN THE MID-LCX (3.0X15MM STENT) (REF: MDR 2953738-2001-00280); (2.5 X 30 MM STENT) (REFL MDR 2953738-2001-00279). IT WAS REPORTED ON THE SAME DAY, THE PT SUFFERED AN ACUTE NON-STEMI (POSTERIOR INFARCTION). THE PCI WAS COMPLETED WITHOUT COMPLICATION. THE PT EXPERIENCED PAIN AFTER THE PCI, REVISION OF THE PCI FILM REVEALED AN OCCLUSION OF A LITTLE SIDE BRANCH OF THE RCX. INVESTIGATOR ACCEPTED THE CONSEQUENCES OF A SMALL MI. THE PT WENT BACK TO THE REFERRING HOSP (CK MAX: 668 U/L, CKMB MAX: 153 U/L; ASAT MAX: 153 U/L). IT WAS REPORTED THAT THE TARGET LESION WAS INVOLVED, BUT THAT THE EVENT WAS NOT RELATED TO THE STENT. THE INVESTIGATOR ASSESSED THE EVENT AS A NON Q-WAVE MI. IT WAS REPORTED THAT THE INVESTIGATOR FELT THAT THE INCIDENT WAS PROCEDURE RELATED. PLEASE NOT THAT THIS MODEL # ENSP25030X IS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX NIQ MEDTRONIC CARDIO VASCULAR GALWAY NA 0000553770

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK