BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 5828768 · Received July 28, 2016

    Report

    Report Number
    9612164-2016-00724
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    July 25, 2013
    Report Date
    June 28, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: "UNRUPTURED ANEURYSM OF THE LEFT SINUS OF VALSALVA COMPRESSING THE LEFT MAIN CORONARY ARTERY SUCCESSFUL PERCUTANEOUS TREATMENT." P. HAUSINGER1 · V. SASI1 · G. VOLFORD2 · M. BITAY3 · G. BOGÁTS3 · A. THURY1 · A. PALKÓ4 · T. FORSTER5 · A. NEMES5 HERZ 2014 · 39:770¿773 DOI 10.1007/S00059-013-3891-2.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD PREVIOUSLY BEEN TREATED FOR FRACTURED RIBS AND HOSPITALIZED FOR HIGH GRADE FEVER AND SEPSIS DUE TO ABSCESS FORMATION IN THE CHEST WALL AT THE SITE OF THE RIB FRACTURE. AFTER 2 WEEKS OF RECOVERY FROM SEPSIS, PATIENT DEVELOPED SEVERE CHEST OPPRESSION AT REST ACCOMPANIED BY ST-SEGMENT DEPRESSION (STD) WITH T-WAVE INVERSION IN LEADS V2-6 ON ELECTROCARDIOGRAPHIC (ECG) TRACINGS AND WAS URGENTLY REFERRED TO THE CARDIAC CATHETERIZATION LABORATORY WITH NON-ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION. ON ADMISSION, AORTOGRAPHY SUGGESTED UNRUPTURED LSVA, AND SELECTIVE CORONARY ANGIOGRAPHY REVEALED PROXIMAL SUBOCCLUSION OF THE LEFT CIRCUMFLEX ARTERY (LCX) BY EXTRINSIC COMPRESSION OF THE LSVA. ONE INTEGRITY BMS STENT WAS IMPLANTED IN THE LCX WITH NO MALFUNCTIONS REPORTED. THE PATIENT REMAINED STABLE FOR 30 HOURS , THEN SUDDENLY DEVELOPED CARDIOGENIC SHOCK WITH SEVERE ANGINA AND STD IN PRECORDIAL LEADS. EMERGENCY SURGERY WAS PERFORMED UNDER CONVENTIONAL CARDIOPULMONARY BYPASS. CORONARY FLOW WAS SECURED BY SAPHENOUS VEIN (SV) BYPASS TO THE LEFT ANTERIOR DESCENDING (LAD) AND LCX ARTERIES. THIS COMPLEX SURGERY WAS PERFORMED WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM HOSPITAL IN GOOD CONDITION 1 MONTH AFTER THE OPERATION. FOUR MONTHS POSTOPERATIVE, THE PATIENT WAS READMITTED WITH A 1-WEEK HISTORY OF EXERTIONAL CHEST PAIN. THE SV GRAFT TO THE LAD WAS PATENT. THE STENT, PREVIOUSLY DEPLOYED IN THE LCX, WAS OCCLUDED BUT THE VESSEL WAS SUPPORTED BY THE WIDELY PATENT SV GRAFT TO THE LCX. PATIENT WAS TREATED WITH A NON-MDT STENT IN THE LMCA. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED 2 DAYS LATER, FREE OF ANGINA. AT THE 3-MONTH FOLLOW-UP, PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482076 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention