BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1053604 · Received May 23, 2008

    Report

    Report Number
    2953200-2008-00362
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.75 MM DIAMETER X 24 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A MID CIRCUMFLEX LESION. LESION MORPHOLOGY WAS REPORTED TO BE MODERATE TORTUOSITY WITH NO CALCIFICATION AND 70% STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.0 X 20 SPRINTER. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE ENDEAVOR SDS AND WAS ATTEMPTING TO REACH THE LESION SITE, HOWEVER, HE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM AND THE STENT MOVED TO THE PROXIMAL PORTION OF THE STENT DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO TAKE OUT THE SYSTEM; HOWEVER, THE STENT FLOATED INTO THE AORTA. THE STENT WAS FOUND TO BE IN A VESSEL IN THE LEG AND REMAINS IN THE PT. THE PT IS FINE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT. MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE DEVICE WAS TWISTED AND KINKED 26.5CM FROM THE DISTAL TIP/IMMEDIATELY DISTAL TO THE WIRE EXCHANGE PORT. CRIMP/BAKE IMPRESSIONS WERE EVIDENT ON THE UN-INFLATED BALLOON AND THE BALLOON PILLOWS WERE PRESENT. THE STENT WAS NOT PRESENT ON THE BALLOON AND WAS NOT RETURNED. THE DISTAL TIP WAS FLARED. BOTH THE INNER AND OUTER SHAFTS WERE TWISTED DISTAL TO THE WIRE ENTRY PORT, THIS MOST LIKELY OCCURRED DURING TWISTING OF THE SHAFT DURING HANDLING OR POSSIBLY DURING ATTEMPTS TO CROSS THROUGH THE LESION. THE DAMAGE PRESENT ON THE DISTAL TIP OF THE DEVICE WAS CONSISTENT WITH THE TIP HAVING MET RESISTANCE DURING USE RESULTING IN THE FLARING OF THE TIP TUBING. THE FOLDS OF THE BALLOON WERE DISTURBED AND PARTIALLY OPENED. THE DISTIAL AND PROXIMAL BALLOON PILLOWS WERE DISTURBED AND SLIGHTLY FLATTENED. REVIEW OF THE PROCEDURAL IMAGES FROM THE CD PROVIDED CONFIRMED THE PRESENCE OF A DISLODGED STENT ON THE WIRE IN THE VESSEL IMMEDIATELY PROXIMAL TO THE LESION SITE. IMAGES OF THE BALLOON USED FOR PRE-DILATATION SHOW THAT THE LESION WAS LOCATED ON A BEND IN THE VESSEL AND THAT THE UN-UNIFORM EXPANSION OF THE BALLOON SUGGESTS THAT THE BALLOON MAY NOT HAVE SUFFICIENTLY OPENED THE LESION TO FACILITATE THE DELIVERY OF THE STENT THROUGH THE LESION SITE. COMMUNICATIONS FROM THE FIELD HAVE INDICATED THAT THE STENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES BEING NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR NA 0000416717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention