BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5113945 · Received September 30, 2015

    Report

    Report Number
    9612164-2015-01574
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    May 22, 2015
    Report Date
    September 11, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD A 99% PROXIMAL LAD LESION AND 90% OR GREATER LONG STENOSIS IN THE MID TO DISTAL CIRCUMFLEX. PHYSICIAN USED A SPRINTER LEGEND BALLOON TO PRE-DILATE THE LESION IN THE LAD. PHYSICIAN SUCCESSFULLY DEPLOYED TWO RESOLUTE INTEGRITY 2.25X30MM <(>&<)> 3.50 X 9MM STENTS IN THE LAD. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED ONE RESOLUTE INTEGRITY 4.00 X STENT (PREVIOUSLY REPORTED AS 4.00 X 38MM) IN THE 2ND OM. THE PHYSICIAN OBSERVED THERE WAS SOME CONSTRICTION OF THE DISTAL 1/3 OF THE STENT BALLOON AND THE PROXIMAL 2/3RD OF THE STENT BALLOON APPEARED TO HAVE A SLIGHTLY LARGER DIAMETER THAN A 4.0MM. APPEARANCE SEEMED GIVEN THE CONSTRICTION OF THE DISTAL ASPECT OF THE STENT BALLOON, THE PRESSURE MOVED TO THE PATH OF LEAST RESISTANCE IN THE PROXIMAL 2/3 OF THE BALLOON WHICH APPEARED SLIGHTLY LARGER THAN THE 4.0MM DIAMETER SIZE. WHEN THE STENT BALLOON WAS DEFLATED, THE STENT WAS DEPLOYED AND A SMALL PERFORATION WAS NOTED ON THE DISTAL ASPECT OF THE STENT IN THE DISTAL CIRCUMFLEX. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED ONE NON MDT STENT IN THE 2ND OM (TO TREAT PERFORATION). THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED ONE RESOLUTE INTEGRITY 2.50 X 22MM STENT (PREVIOUSLY REPORTED AS 4.00 X 38MM) IN THE 2ND OM. PHYSICIAN USED A NON-MDT BALLOON TO POST-DILATE THE 2ND OM. LATER IN THE DAY, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND PATIENT RETURN TO THE CCL AND THE PHYSICIAN IMPLANTED ANOTHER NON-MDT STENT IN THE 2ND-OM AND POST DILATED IT WITH AN NC EUPHORIA. PATIENT DISCHARGED FROM CCL LAB AND LATER THAN EVENING OR NIGHT, PATIENT EXPERIENCED CHEST PAIN AND DIED. THE ANTICOAGULATION WAS REVERSED SO STENT THROMBOSIS IS ANOTHER POSSIBILITY. THE PHYSICIAN SAID CAUSE OF DEATH WAS CARDIOGENIC SHOCK/MULTI ORGAN FAILURE. NO AUTOPSY WAS PERFORMED. IMAGE REVIEW: IMAGES CONFIRM THE PRESENCE OF DISEASE IN BOTH LEFT CORONARY ARTERIES. THE LAD PROXIMAL LESION WAS INITIALLY TREATED WITH A STENT MOST LIKELY THE 2.25 X 30MM RESOLUTE INTEGRITY DEVICE. THERE WAS STILL AN UNTREATED PORTION IN THE PROXIMAL LAD AND THIS APPEARS TO HAVE BEEN TREATED WITH A 3.5 X 9MM RESOLUTE INTEGRITY STENT. THROMBUS APPEARED TO BE PRESENT PROXIMAL TO THE LESION SITE PRIOR TO SUCCESSFUL STENTING AND POST DILATATION OF THE LAD. THE LCX/OM LESION WAS THEN TREATED. STENT DEPLOYMENT IN THE PROXIMAL TO MID VESSEL WAS COMPLETED WITH WHAT APPEARS TO BE A 4.0 X 30MM RESOLUTE INTEGRITY STENT AS REPORTED IN THE PROCEDURAL NOTES. THE EXPANSION OF THE STENT ON THE DISTAL SIDE OF THE LESION APPEARED TO SHOW RESISTANCE TO FULL EXPANSION. THE PROXIMAL END OF THE STENT APPEARED TO DEPLOY TO A LARGER DIAMETER THAN THE DISTAL PORTION OF THE STENT. THIS WAS MOST LIKELY DUE TO THE PRESENCE OF CALCIFICATION IN THE DISTAL PART OF THE LESION CAUSING THE LESION RESISTANCE TO EXPANSION. THERE IS NO EVIDENCE TO SUGGEST THAT THERE WAS ANY DEVICE MALFUNCTION DURING STENT DEPLOYMENT. THE BALLOON/STENT SELECTION USED FOR THIS VESSEL APPEARS TO BE OVERSIZED BASED ON THE VESSEL DIAMETER, AND LONG BASED ON THE LESION LENGTH. THE INFLATION PRESSURE OF THE RESOLUTE INTEGRITY STENT IS UNKNOWN BUT THE INFLATION PRESSURE USED FOR STENT DEPLOYMENT MAY HAVE IMPACTED ON THE RESULTING DISSECTION. THERE IS NO EVIDENCE OF THE NON MDT ANGIOPLASTY BALLOON IN THE IMAGES THAT WAS REPORTED TO HAVE BEEN ADVANCES AS PER THE PROCEDURE NOTES. A DISSECTION APPEARS TO HAVE OCCURRED IN THE VESSEL, MOST LIKELY DUE TO THE CRACKING OF THE DISTAL SIDE OF THE LESION DURING STENT EXPANSION. THIS RESULTED IN THE DISTAL LCX SHUTTING DOWN. THE PROCEDURAL WIRE WAS REMOVED AND THE VESSEL WAS SUBSEQUENTLY RE--WIRED, PRIOR TO THE DEPLOYMENT OF A 4.0 X 19MM NON-MDT COVERED STENT TO TREAT THE REPORTED PERFORATION OF THE VESSEL. THE 2.5 X 22MM RESOLUTE INTEGRITY STENT WAS DELIVERED AND DEPLOYED DISTAL TO AND OVERLAPPING THE NON-MDT STENT. APPROXIMATELY 6 HOURS POST INITIAL TREATMENT THE ANGIOGRAMS SHOW WHAT APPEARS TO BE VESSEL PERFORATION FROM THE OM AT PROXIMAL EDGE OF THE PREVIOUSLY DEPLOYED NON-MDT STENT. THIS PERFORATION WAS NOT EVIDENT ON THE IMAGES ON COMPLETION OF THE INITIAL TREATMENT. A 2.8 X 19MM COVERED NON-MDT STENT WAS DEPLOYED TO TREAT THE PERFORATION. THERE IS NO EVIDENCE ON THE IMAGES OF THE NC EUPHORA BALLOON THAT WAS USED POST NON-MDT STENT DEPLOYMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645772 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death| R