BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2971929 · Received February 21, 2013

    Report

    Report Number
    9612164-2013-00195
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-HEAVY CALCIFICATION, CAUSED THE INITIAL ISSUE WITH CROSSING AND THE STENT BECOMING STUCK WITHIN THE VESSEL. DEFORMATION PROBLEM- DETACHMENT OF DEVICE; RELATED TO OPERATIONAL CONTEXT-DETACHMENT HAS MOST LIKELY OCCURRED DUE TO THE ATTEMPTS TO REMOVE THE DEVICE FROM THE VESSEL. CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-HEAVY CALCIFICATION, CAUSED THE INITIAL ISSUE WITH CROSSING AND THE STENT BECOMING STUCK WITHIN THE VESSEL. OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT -DETACHMENT HAS MOST LIKELY OCCURRED DUE TO THE ATTEMPTS TO REMOVE THE DEVICE FROM THE VESSEL. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE MID LAD WHICH WAS REPORTED TO BE A CHRONIC TOTAL OCCLUSION. THE LESION WAS SUCCESSFULLY PRE-DILATED. DURING DELIVERY THE STENT BECAME ENTRAPPED UPON HEAVY CALCIFICATION. AS THE PHYSICIAN ATTEMPTED TO WITHDRAW WITH SIGNIFICANT TENSION, THE DELIVERY CATHETER FRACTURED. THE PATIENT HAD TO GO TO THE OPERATING ROOM FOR SURGERY TO HAVE IT REMOVED. THE PATIENT IS REPORTED TO BE DOING WELL. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED WITH THE PROCEDURAL GUIDEWIRE AND GUIDE CATHETER. THE GUIDEWIRE WAS STILL LOADED IN THE GUIDE CATHETER. THERE WERE NUMEROUS KINKS EVIDENT ALONG THE HYPO TUBE. THE TRANSITION SHAFT WAS KINKED AND STRETCHED AND HAD DETACHED 20.5CM DISTAL TO THE HYPO TUBE BOND. THE TRANSITION SHAFT DETACHMENT SITE WAS JAGGED AND STRETCHED. ON WITHDRAWAL OF THE GUIDEWIRE FROM THE GUIDE CATHETER THE DISTAL END OF THE TRANSITION SHAFT AND A SECTION OF THE DISTAL SHAFT WERE FOUND ON THE WIRE. THE DISTAL END OF THE TRANSITION SHAFT WAS MEASURED AT 7.7CM FROM THE DETACHMENT SITE TO THE GUIDEWIRE ENTRY PORT BOND. THE DISTAL SHAFT HAD DETACHED 12.6CM DISTAL TO THE GUIDEWIRE ENTRY PORT BOND. THE DISTAL SHAFT DETACHMENT SITE WAS JAGGED. THE OVERALL GUIDEWIRE LENGTH WAS MEASURED AT 155.7CM. THERE WERE NUMEROUS KINKS ALONG THE GUIDEWIRE. THE DISTAL COILED SECTION OF THE GUIDEWIRE HAD DETACHED. THE OVERALL GUIDE CATHETER LENGTH WAS MEASURED AT 98.2CM. THERE WERE KINKS EVIDENT ALONG THE GUIDE CATHETER AND THE DISTAL TIP HAD DETACHED. THE DETACHMENT SITE WAS OVAL AND JAGGED.

    Description of Event or Problem · 1

    CORONARY ARTERY BYPASS GRAFTING CARRIED OF THE LAD CARRIED OUT REQUIRED IN TREATMENT OF THE PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76403 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006556751

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention