BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1037115 · Received May 2, 2008

    Report

    Report Number
    2953200-2008-00281
    Event Type
    Injury
    Date Received
    May 2, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR 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

    EVAL RESULTS/CONCLUSION: MYOCARDIAL INFARCTION. OTHER (LACK OF INFO).

    Description of Event or Problem · 1

    PT HAD A HISTORY OF HYPERTENSION. THREE ENDEAVOR STENTS WERE IMPLANTED IN THE PT ONE MONTH AGO. ONE ENDEAVOR STENT WAS IMPLANTED IN THE MID-RCA (3.5 X 30 MM STENT) (REF: MDR 2953738-2001-00281). TWO ENDEAVOR STENTS WERE IMPLANTED IN THE MID-LCX (3.0 X 15 MM STENT) (REF: MDR 2953738-2001-00280) (2.5 X 30 MM STENT) (REF: 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 HOSPITAL (CK MAX: 669 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 NOTE THAT THIS MODEL NUMBER ENSP35030X IS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000649697

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK