BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1071335 · Received July 8, 2008

    Report

    Report Number
    2953200-2008-00513
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    April 22, 2008
    Report Date
    June 10, 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

    EVALUATION RESULTS. MYOCARDIAL INFARCTION, STENT THROMBOSIS. LACK OF INFO. PCI INSTRUMENTATION. CONCLUSION: PCI INSTRUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION TREATED WAS LOCATED IN THE MID RCA. ONE ENDEAVOR SPRINT RX STENT WAS IMPLANTED (3.5 X 9MM). AFTER INITIAL PCI, THERE WAS DISSECTION OF THE VESSEL. THEREFORE, EMERGENCY PCI OF TARGET VESSEL WAS CARRIED OUT. THE FIRST LESION TO BE REVASCULARIZED WAS THE RAMUS BRANCH. THE INDICATION FOR REVASCULARIZATION WAS OBJECTIVE SIGNS OF ISCHEMIA AT REST OR DURING EXERCISE TEST. ONE ENDEAVOR SPRINT RX STENT WAS IMPLANTED (3.0 X 15MM). THE SECOND LESION TO BE REVASCULARIZED WAS THE DISTAL RCA (TARGET VESSEL). (MFR REPORT# 2953200-2008-00511-00513). THE INVESTIGATOR INDICATED THAT THE REVASCULARIZATION EVENT WAS RELATED TO THE ENDEAVOR SPRINT DEVICE. ONE ENDEAVOR SPRINT RX STENT WAS IMPLANTED (3.0 X 9MM). THE SAME DAY THE PATIENT SUFFERED AN ACUTE NON-STEMI AS A RESULT OF DISSECTION OF THE VESSEL, AFTER INITIAL PICI. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS RELATED TO THE TARGET LESION AND THE ENDEAVOR SPRINT DEVICE. LOCATION OF INFARCTION WAS POSTERIOR, INFERIOR. THE PT WAS ASYMPTOMATIC AT THE 30-DAY FOLLOW-UP STAGE. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000563173

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention