BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2002419 · Received January 28, 2011

    Report

    Report Number
    2953200-2011-00196
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 31, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (OPERATIONAL CONTEXT OF THE DEVICE AND THE RESISTANCE EXPERIENCED BY THE PHYSICIAN), (FAILURE TO DELIVER AND STENT EMBOLISM), (STRETCHING AND DAMAGE TO THE SHAFT SUGGESTS THAT FORCE WAS USED DURING HANDLING OF THE DEVICE). EVAL: CONCLUSION: (OPERATIONAL CONTEXT OF THE DEVICE AND THE RESISTANCE EXPERIENCED BY THE PHYSICIAN), (STRETCHING AND DAMAGE TO THE SHAFT SUGGESTS THAT FORCE WAS USED DURING HANDLING OF THE DEVICE). EVAL SUMMARY: THE STENT DELIVERY SYS (SDS) WAS RETURNED, WITHOUT THE STENT PRESENT ON THE BALLOON. THE TRANSITION TUBING WAS STRETCHED AND KINKED. BLOOD RESIDUE WAS EVIDENT INSIDE THE INFLATION LUMEN AND BALLOON. THE PROXIMAL AND DISTAL BALLOON CONES WERE PARTIALLY INFLATED. CRIMP/ BAKE IMPRESSIONS WERE EVIDENT ON THE EXPOSED BALLOON. THE GUIDE WIRE ENTRY PORT, DISTAL PORT AND INNER SHAFTS WERE SEVERLY TORN WITH A CHATTER MARK EFFECT. THERE WAS 1 CM OF THE CORE WIRE EXPOSED DISTAL TO THE GUIDE WIRE ENTRY PORT. THE TRANSITION SHAFT WAS STRETCHED AND KINKED. NEGATIVE PREP CONFIRMED THE PRESENCE OF A LEAK IN THE DEVICE. A LEAK WAS DETECTED AT THE TEAR SITE AT THE GUIDE WIRE ENTRY PORT. THE DISTAL SHAFT WAS CUT IN TWO IMMEDIATELY DISTAL TO THE TEAR SITE AND IT WAS POSSIBLE TO INFLATE THE BALLOON OF THE SDS TO NOMINAL AND RATED BURST PRESSURE WITH NO ISSUES NOTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO IMPLANT AN ENDEAVOR RESOLUTE 4.0 MM DIAMETER X 30 MM LENGTH STENT RAPID EXCHANGE (RX) IN THE LAD. AFTER POSITIONING THE STENT AT THE LESION SITE THE PHYSICIAN WAS UNABLE TO INFLATE THE DEVICE AND WITHDREW THE DEVICE. IT WAS REPORTED THAT THE STENT REMAINED IN THE PT AND THE PHYSICIAN USED 8 SEMI COMPLAINT BALLOONS TO FINALLY DEPLOY THE STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0004521874

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention