BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6176782 · Received December 15, 2016

    Report

    Report Number
    9612164-2016-01311
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169037168
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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.

    Description of Event or Problem · 1

    PATIENT WAS SENT HOME ON MAXIMUM MEDICAL THERAPY AS SURGERY WAS NOT AN OPTION. THE ANGINA PERSISTED AND THE PATIENT RETURNED TO THE ER 3 DAYS LATER WITH UNRELENTING CHEST PAIN. DIAGNOSTIC CATHETER SHOWED A SEVERELY CALCIFIED NON-TORTUOUS OSTIUM CX LESION. IVUS SHOWED SIGNIFICANT PLAQUE BURDEN. THE LEFT MAIN WAS PRE-DILATED WITH AN NC EUPHORA BALLOON WITH NO ISSUES NOTED. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 3.0MMX22MM RESOLUTE INTEGRITY STENT FROM THE LM TO THE CIRCUMFLEX..THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT WHEN THEY DEPLOYED THE RESOLUTE INTEGRITY STENT THE PATIENT HAD A SPIRAL DISSECTION IN THE CIRCUMFLEX AND STARTED TO LOSE CIRCULATION. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE CALCIFIED AREA OF THE VESSEL WAS AFFECTED BY THE STENT PLACEMENT. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE 2 X RESOLUTE INTEGRITY 2.50MMX18MM STENTS IN THE CIRCUMFLEX TO SALVAGE THE ARTERY. BOTH STENTS PASSED THROUGH PREVIOUSLY DEPLOYED STENTS. NO RESISTANCE OR EXCESSIVE FORCE WAS USED DURING DELIVERY FOR THE FIRST OF THESE 2 STENTS WHILE NO EXCESSIVE FORCE WAS REPORTED FOR THE NEXT STENT. BOTH DEVICES WERE INSPECTED AND NEGATIVE PREP WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE ATTEMPT TO SALVAGE THE ARTERY DID NOT MAINTAIN CIRCULATION AND THE PATIENT EXPIRED. ATTEMPTS WERE MADE TO REVIVE THE PATIENT BUT THIS WAS HAMPERED WITH A LV FUNCTION OF 25%. THE PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. PHYSICIAN DETERMINED THE CAUSE OF DEATH AS FOLLOWS 'DISSECTION IN CIRCUMFLEX CAUSED SHORT PERIOD OF NO REFLOW WHICH RESULTED IN HEMODYNAMICS COMPROMISE AND ELECTROMECHANICAL DISASSOCIATION WHICH COULDN'T BE RESTORED AFTER SUCCESSFUL PLACEMENT OF LEFT MAIN AND CIRCUMFLEX STENTS RESTORING CORONARY BLOOD FLOW". PHYSICIAN BELIEVES THAT THE DISSECTION WAS RELATED TO DIFFICULT LESION MORPHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829500 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007968531 00643169037168

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death