BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3982571 · Received August 6, 2014

    Report

    Report Number
    9612164-2014-01023
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). FAILURE TO FOLLOW INSTRUCTIONS ¿ (THE IFU INSTRUCTS THE USER TO NOT USE THE PRODUCT IF DAMAGED PRIOR TO USE. THE SHAFT WAS STRAIGHTENED BY THE USER PRIOR TO INSERTION). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (NONE) ¿ DEVICE NOT RETURNED FOR EVALUATION. EVALUATION CONCLUSIONS: FAILURE TO FOLLOW INSTRUCTIONS ¿ (THE IFU INSTRUCTS THE USER TO NOT USE THE PRODUCT IF DAMAGED PRIOR TO USE. THE SHAFT WAS STRAIGHTENED BY THE USER PRIOR TO INSERTION) - (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (DEFORMATION PROBLEM). (B)(4)

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTE INTEGRITY 3.0X18MM STENT. TARGET LESION WAS IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS REMOVED FROM THE PACKAGING WITH NO ISSUES NOTED. BEFORE INSERTING DEVICE INTO THE PATIENT, IT WAS NOTICED THAT SHAFT WAS KINKED. IT IS REPORTED THAT A "SMALL BEND MIGHT HAVE HAPPENED AS PRODUCT WAS ON TABLE AND WAS BEING ATTACHED TO INDEFLATOR." PHYSICIAN STRAIGHTENED KINK IN CATHETER AND ADVANCED THE DEVICE INTO THE PATIENT. WHEN ADVANCING, THE SHAFT OF THE CATHETER SNAPPED IN THE PATIENT. A SNARE WAS NOT ABLE TO BE USED. PHYSICIAN WAS ABLE TO PULL BACK THE ENTIRE SYSTEM OUT OF THE PATIENT. THEY CATHETER WAS RE-ENGAGED AND WIRE INSERTED. A NON-MEDTRONIC STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DELIVERY SYSTEM WAS BROKEN IN TWO, THE BREAK OCCURRED AT 76CM DISTAL FROM THE STRAIN RELIEF. THE PROXIMAL SECTION OF THE DEVICE WAS KINKED WHERE THE HYPOTUBE IS ATTACHED TO THE STRAIN RELIEF. THE PROXIMAL SECTION WAS ALSO KINKED ON THE HYPOTUBE AT A NUMBER OF SECTIONS AT 17CM, 37CM AND 49CM DISTAL TO THE STRAIN RELIEF. THE DISTAL SECTION OF THE DELIVERY SYSTEM ALSO HAD A NUMBER OF KINKS LOCATED ON IT AT 21CM, 36CM, 49.5CM, 52CM AND 60.5CM. THE DISTAL TIP OF THE DEVICE HAD NO EVIDENCE OF DAMAGE. THE MIDDLE SECTION OF THE STENT HAD RAISED AND STRETCHED STRUTS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460623 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007131776

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR