BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 7070017 · Received November 30, 2017

    Report

    Report Number
    9612164-2017-01690
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    November 24, 2016
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: DOI 10.1007/S12928-016-0445-6.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT HAD A PREVIOUS NON-MDT BARE METAL STENT (BMS) IMPLANTED INTO THE HIGH LATERAL SEVEN YEARS AGO. IT WAS NOTED THAT THE PHYSICIAN HAS COMMENTED THAT THE ADVERSE EVENTS MENTIONED IN THE ARTICLE ARE NOT RELATED TO THE RESOLUTE INTEGRITY BUT ARE PATIENT RELATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AT ADMISSION THE PATIENT EXHIBITED ST SEGMENT ELEVATION, CARDIOMEGALY WITH LUNG CONGESTION, PANCYTOPENIA AND INCREASED CREATININE AND CARDIAC ENZYMES. THE PATIENT WAS DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION (AMI) WITH HEART FAILURE AND ACUTE KIDNEY INJURY. THE PATIENT EXHIBITED SEVERE STENOSIS IN THE JUST PROXIMAL LAD AND DISTAL RCA, WITH CTO IN THE LCX. APPROXIMATELY ONE MONTH AFTER DISCHARGE THE PATIENT WAS RE-ADMITTED FOR RECURRENT AMI, COMPLICATED WITH HEART FAILURE AND A MARKED ST SEGMENT CHANGE. DUE TO THE DEVELOPMENT OF REFRACTORY HEART FAILURE CONCOMITANT WITH RENAL FAILURE, IMMEDIATE TRANSRADIAL CAG/PCI WAS PERFORMED. THE PATIENT HAD A PREVIOUS UNKNOWN BRAND OF BARE METAL STENT (BMS) IMPLANTED IN AN INTERMEDIATE BRANCH. DURING THE PROCEDURE, THE PATIENT WAS ADMINISTERED UNFRACTIONATED HEPARIN. THE DISTAL RCA EXHIBITED SUBTOTAL OCCLUSION, THE LAD EXHIBITED SEVERE STENOSIS, WITH IN-STENT RESTENOSIS IN THE INTERMEDIATE BRANCH AND TOTAL OCCLUSION IN THE MID LCX. THE OSTIAL LAD LESION WAS CONCLUDED AS THE AMI CAUSE. IVUS REVEALED PLAQUE, POTENTIALLY DEEP CALCIFICATION AND A CAVITY, MOST LIKELY DUE TO PLAQUE RUPTURE IN THE JUST PROXIMAL LAD. IN-STENT INTIMAL THICKENING WITH SUPERFICIAL CALCIFICATION WAS REVEALED IN THE INTERMEDIATE BRANCH. DURING THE PROCEDURE, AFTER PRE-DILATION, AN INTEGRITY BMS (3.5X12MM) WAS DIRECTLY IMPLANTED FROM THE LMCA TO THE PROXIMAL LAD UNDER IVUS GUIDANCE, JAILING THE LCX AND INTERMEDIATE BRANCH. AFTER WIRE-RECROSSING OF THE INTERMEDIATE BRANCH, A KISSING BALLOON INFLATION WAS PERFORMED. FINAL IVUS SHOWED COMPLETE STENT APPOSITION WITH OPTIMAL PLACEMENT. POST PROCEDURE THE PATIENT RECEIVED UNFRACTIONATED HEPARIN FOR TWO WEEKS, WITH ONGOING DAILY ASPIRIN. ON THE NINTH HOSPITAL DAY THE PATIENT COMPLAINED OF EPISTAXIS, WHICH HEALED WITH PC TRANSFUSION, AND WAS DISCHARGED WITH SINGLE ANTIPLATELET THERAPY AND ASPIRIN ON THE 18TH HOSPITAL DAY. A FEW DAYS AFTER DISCHARGE, RIGHT-SIDED HEMIPARESIS WAS NOTED. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL 8 DAYS AFTER DISCHARGE, AND DIAGNOSED WITH LEFT-SIDED CHRONIC SUBDURAL HEMATOMA. REPEAT HEMATOMA EVACUATION WAS PERFORMED TO TREAT THE SUBDURAL HEMATOMA. DESPITE MILD DYSPNEA ON EFFORT DUE TO HEART FAILURE AND ANAEMIA, THE PATIENT IS SINCE FREE OF CARDIOVASCULAR EVENTS AND BLEEDING COMPLICATIONS UNDER PC/RCC TRANSFUSIONS ONCE A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849058 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0007284730

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention