BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2102975 · Received May 12, 2011

    Report

    Report Number
    9612164-2011-00423
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEVICE EVAL PENDING), (BALLOON OF SDS WAS USED FOR PRE-DILATATION). CONCLUSION: NO CONCLUSION CAN BE DRAWN (DEVICE EVAL PENDING), (BALLOON OF SDS WAS USED FOR PRE-DILATATION).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO IMPLANT AN ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENT DIAMETER 3.5 MM LENGTH 30 MM IN A PT. IT WAS REPORTED THAT WHEN THE PHYSICIAN TOOK THE DEVICE FROM THE PACKAGE AND REMOVED THE PROTECTIVE SHEATH, THE STENT WAS REMOVED WITH THE SHEATH. THE DELIVERY SYSTEM WAS USED TO PRE-DILATATE THE TARGET LESION. ANOTHER NON-MEDTRONIC STENT WAS USED TO COMPLETE THE PROCEDURE. NO HEALTH HAZARD WAS CAUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001356386

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK