BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5965877 · Received September 21, 2016

    Report

    Report Number
    9612164-2016-00984
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    April 24, 2015
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JOURNAL: CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS ARTICLE TITLE: INCIDENCE AND MECHANISMS OF OF LONGITUDINAL STENT DEFORMATION ASSOCIATED WITH BIOMATRIX, RESOLUTE, ELEMENT, AND XIENCE STENTS DOI: 10.1002/CCD.25790. EVENT DATE IS DATE OF ARTICLE PUBLICATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A CLINICAL STUDY WAS CARRIED OUT INVOLVING RESOLUTE INTEGRITY DRUG ELUTING STENTS AND OTHER NON MDT BRAND STENTS WITH A TOTAL OF 1800 PCI CASES. 450 PCI PROCEDURES USING RESOLUTE INTEGRITY DEVICES WERE WITHIN THE SCOPE OF THE STUDY. COLLECTIVELY THE LM, LAD, LCX, RCA AND VG VESSELS EXHIBITING CHRONIC TOTAL OCCLUSION, ISR, CALCIFICATION AND VESSEL TORTUOSITY WERE TREATED. DURING THE PROCEDURES LSD (LONGITUDINAL STENT DEFORMATION) OCCURRED IN 3 CASES. SECOND DEVICE LSD WAS REPORTED TO HAVE OCCURRED INVOLVING ENDEAVOR RESOLUTE. MAJOR COMPLICATIONS CAUSED BY LSD INCLUDING STENT THROMBOSIS, EMERGENCY CABG AND DEATH WERE REPORTED TO HAVE OCCURRED IN A PORTION OF STUDY PARTICIPANTS. MAJOR COMPLICATIONS CAUSED BY LSD INCLUDING STENT THROMBOSIS, EMERGENCY CORONARY ARTERY BYPASS SURGERY (CABG) AND DEATH HAVE BEEN REPORTED AS CASE REPORTS AND IN 7% AND 14% OF CASES IN TWO REPORTS FROM THE MAUDE COMPLICATIONS DATABASE. ALTHOUGH DESCRIBED WITH A VARIETY OF PLATFORMS, THESE REPORTS HAVE HIGHLIGHTED AN ASSOCIATION BETWEEN LSD AND THE PROMUS ELEMENT STENT WHICH HAS ALSO BEEN SHOWN TO BE LESS RESISTANT TO LONGITUDINAL COMPRESSION IN BENCH TESTING STUDIES LSD WAS DESCRIBED IN THE INITIAL PROCEDURE REPORT IN ONLY (B)(6) CASES. OF THE 16 UNRECOGNISED CASES, 13 CASES WERE NEVERTHELESS RE-EXPANDED AND 3 CASES WERE LEFT UNTREATED. IN ONE OF THE THREE UNTREATED CASES STENT THROMBOSIS LEADING TO CARDIOGENIC SHOCK OCCURRED AT THE SITE OF LSD 6 WEEKS POST PROCEDURE. LSD WAS SUCCESSFULLY RE-EXPANDED WITHOUT FURTHER SEQUELAE IN ALL REMAINING CASES. RE-EXPANSION WAS ACHIEVED BY POSTDILATION ALONE IN 12 CASES AND INVOLVED OVERLAPPING WITH A FURTHER STENT IN 9 CASES. HOWEVER, MARKED DIFFICULTY RE-ENTERING THE DEFORMED STENT WAS ENCOUNTERED IN 6 CASES OF SECONDARY DEVICE LSD ((B)(6) TREATED CASES) THAT REQUIRED THE USE OF MULTIPLE SMALL DIAMETER BALLOONS _1.5 MM TO RE-ENTER THE DEFORMED STENT. DIFFICULTY REENTERING THE STENT WAS NOT ENCOUNTERED IN GUIDE CATHETER LSD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618900 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR