BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVESTIGATIONAL ENDEAVOR OTW

    MDR report key: 1033593 · Received April 23, 2008

    Report

    Report Number
    2953200-2008-00245
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 25, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER - LACK OF INFO. OTHER - MEDICAL INTERVENTION, GI COMPLICATION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYS WAS IMPLANTED INTO A PT FOR THE TREATMENT OF A CORONARY LESION. AT 22 MONTHS POST STENT IMPLANT, IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSP WITH RECTAL BLEEDING AND EPIGASTRIC PAIN. EGD REVEALED DUODENITIS AND GASTRITIS WHICH IMPROVED WITH MEDICATIONS. THE PT WAS DISCHARGED FROM THE HOSPITAL 6 DAYS LATER. TWO MONTHS LATER, THE PT WAS ADMITTED TO THE HOSPITAL WITH MILD CHEST PAIN (CATH NEGATIVE) AND RECTAL BLEEDING. THE PT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER. THE INVESTIGATOR'S ASSESSMENT WAS THAT THERE WAS NO RELATIONSHIP TO THE STUDY DEVICE NOR INDEX PROCEDURE. NO FURTHER INFO HAS BEEN OBTAINED. PLEASE NOTE THAT THIS DEVICE IS AN INVESTIGATIONAL DEVICE AND IS SIMILAR TO THE US DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVESTIGATIONAL ENDEAVOR OTW NIQ MEDTRONIC CARDIO VASCULAR NA 660355

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention