BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3063329 · Received April 17, 2013

    Report

    Report Number
    9612164-2013-00433
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE-THROMBOSIS, OCCLUSION, TVR, REACTION AND MI; PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-VESSEL CONTAINED THROMBUS PRIOR TO PLACING THE RESOLUTE INTEGRITY STENTS; NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE NOT RETURNED FOR EVALUATION. CONCLUSION: INHERENT RISK OF PROCEDURE-THROMBOSIS, OCCLUSION, TVR, REACTION AND MI; PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-VESSEL CONTAINED THROMBUS PRIOR TO PLACING THE RESOLUTE INTEGRITY STENTS. (B)(4).

    Description of Event or Problem · 1

    IMAGE REVIEW THE IMAGES CONFIRM A CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL LAD WITH VESSEL STENOSIS PROXIMAL TO THE OCCLUSION SITE. THE CTO LESION IS PRE-DILATED FOLLOWED BY PLACEMENT AND DEPLOYMENT OF THE FIRST RESOLUTE INTEGRITY STENT. NO DEPLOYMENT ISSUES WERE OBSERVED. THERE IS EVIDENCE OF THROMBUS WITHIN THE NEWLY DEPLOYED STENT. THE THROMBUS APPEARS TO HAVE MOVED PROXIMALLY RESULTING IN BLOCKAGE TO THE VESSEL PROXIMAL TO THE NEWLY DEPLOYED STENT. THE SECOND RESOLUTE INTEGRITY STENT IS THEN DEPLOYED. NO DEPLOYMENT ISSUES WERE OBSERVED. DEPLOYMENT OF THE SECOND STENT FAILED TO RESOLVE THE ISSUE AND THE LAD REMAINED OCCLUDED. DESPITE ATTEMPTS AT FURTHER BALLOONING THE VESSEL THE THROMBUS BURDEN WAS NOT RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT HAD 2 RESOLUTE INTEGRITY DRUG ELUTING STENTS IMPLANTED WITHOUT ANY REPORTED ISSUES. POST IMPLANT (0-24 HOURS) THE PHYSICIAN CLAIMS PATIENT HAD AN ALLERGIC REACTION TO STENT THAT CAUSED THE ARTERY TO CLOT OFF AND PATIENT SUFFERED STENT THROMBOSIS AND ACUTE MYOCARDIAL INFARCTION. BYPASS SURGERY WAS CARRIED OUT IN TREATMENT. IMAGES PROVIDED INDICATES THE VESSEL CONTAINED THROMBUS PRIOR TO PLACING THE RESOLUTE INTEGRITY STENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164341 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention