BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTOPUS 3 TISSUE STABILIZER

    MDR report key: 11278796 · Received February 4, 2021

    Report

    Report Number
    2184009-2021-00005
    Event Type
    Death
    Date Received
    February 4, 2021
    Date of Event
    March 1, 2002
    Report Date
    February 4, 2021
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    MWS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: INTRA MYOCARDIAL DISSECTING HEMATOMA WITH EPICARDIAL RUPTURE  AN UNUSUAL COMPLICATION OF THE OCTOPUS 3 STABILIZER. AUTHORS: N.V. MANDKE, Z.M. NALLADARU, A. CHOUGULE, A.N. MANDKE EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 21 (2002) 566567 DOI: HTTPS://DOI.ORG/10.1016/S1010-7940(01)01102-2. DATE OF EVENT: FIRST DATE OF ONLINE PUBLISHING. PMA / 510(K) # DEVICE OBSOLETE (NO LONGER MANUFACTURED BY MEDTRONIC). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA A LITERATURE CASE STUDY, THAT AN OCTOPUS 3 STABILIZER WAS USED IN AN OFF-PUMP CABG PROCEDURE OF A SINGLE PATIENT. IT WAS REPORTED THAT LIMA WAS USED TO REVASCULARIZE THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND SEPARATE VEIN GRAFTS WERE USED FOR REVASCULARIZING THE POSTERIOR DESCENDING ARTERY (PDA) AND OBTUSE MARGINAL (OM) BRANCH OF CIRCUMFLEX ARTERY. THE ANASTOMOSIS TO THE OM WAS THE LAST TO BE PERFORMED. ON REMOVING THE OCTOPUS A SUBEPICARDIAL HEMATOMA WAS NOTICED ON THE LATERAL MYOCARDIAL WALL WHERE THE SUCTION PADS WERE APPLIED DURING THE LIMA-LAD ANASTOMOSIS. THE HEMATOMA WAS EVACUATED BY MAKING A SMALL NICK ON THE EPICARDIUM. LOCAL PRESSURE WAS APPLIED FOR 15 MIN TO STOP THE OOZING FROM THE NICKED SURFACE. AFTER HEMOSTASIS WAS ENSURED THE CHEST WAS CLOSED AND THE PATIENT WAS SHIFTED TO ICU IN A HEMODYNAMICALLY STABLE CONDITION, AFTER EXTUBATION IN THE OPERATING ROOM. TWO HOURS LATER, THE PATIENT DEVELOPED SIGNS AND SYMPTOMS OF CARDIAC TAMPONADE AS WELL AS EXCESSIVE DRAINAGE FROM THE CHEST TUBES [800 ML IN THE FIRST 3 H FOLLOWING SURGERY]. THE PATIENT WAS BROUGHT BACK TO THE OR AND REOPENED. SOON AFTER OPENING THE CHEST SHE HAD A CARDIAC ARREST AND HAD TO BE GIVEN CARDIAC MASSAGE AND WAS PUT ON CPB URGENTLY. LARGE AMOUNTS OF CLOTS WERE EVACUATED FROM THE PERICARDIAL CAVITY. THE HEMATOMA WAS FOUND TO HAVE EXTENDED OVER THE ANTEROLATERAL WALL OF THE LV. THE EPICARDIAL SURFACE HAD DISSECTED AND HAD A MACERATED, RAW APPEARANCE. THE RAW EPICARDIAL SURFACE WAS ACTIVELY OOZING. THE ANASTOMOSIS TO THE OM WAS INTACT. THE AORTA WAS CROSS-CLAMPED AND ANTEGRADE BLOOD CARDIOPLEGIA WAS GIVEN TO ARREST THE HEART. THE RAW SURFACE OF THE DECOMPRESSED MYOCARDIUM WAS DRIED WITH A SPONGE AND THE BIOLOGIC GLUE WAS APPLIED OVER IT AND THE ADJACENT IN-SITU PERICARDIUM. THE HARDENING SOLUTION WAS THEN MIXED AND THE PERICARDIUM AND THE MYOCARDIUM WERE PRESSED FOR 2 MIN AS RECOMMENDED. THE PERICARDIAL PATCH WAS HELD IN PLACE BY FEW TACKING SUTURES. MICROFIBRILLAR COLLAGEN WAS PLACED ON THE POSTERIOR SURFACE BELOW THE MACERATED AREA FOR LOCAL HEMOSTASIS. THE BONDAGE WAS QUITE GOOD, BUT THE BLEEDING CONTINUED TO A LESSER DEGREE. THE PATIENT WAS WEANED OFF CPB WITH INOTROPIC SUPPORT AND SHIFTED TO THE ICU. IN THE ICU THE PATIENT CONTINUED TO BLEED AND HAD MULTIPLE ATTACKS OF VENTRICULAR TACHYCARDIA AND FIBRILLATION AND DIED 3 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173922 OCTOPUS 3 TISSUE STABILIZER STABILIZER,HEART MWS PERFUSION SYSTEMS 28400

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R