BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3934242 · Received June 27, 2014

    Report

    Report Number
    2916596-2014-00977
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-25/24/12-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. REPORTS OF DISCONNECTION OF THE BEND RELIEF FROM THE SEALED OUTFLOW GRAFT HAVE BEEN ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM, UPDATE DEVICE LABELING, AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596-25/24/12-001-C) AND A SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR) USED TO SECURE THE BEND RELIEF TO THE SEALED OUTFLOW GRAFT AND INCREASE THE ASSEMBLY'S RESISTANCE TO FORCES THAT WOULD TEND TO DISLODGE THE BEND RELIEF. THIS DESIGN MODIFICATION WAS APPROVED IN A PMA SUPPLEMENT AND HAD BEEN IMPLEMENTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORT OF AN OUTFLOW GRAFT BEND RELIEF CAN BE CONFIRMED BASED ON THE EVALUATION OF (B)(4). X-RAYS OF THE PATIENT¿S IMPLANTED PUMP REVEALED THAT THE OUTFLOW GRAFT BEND RELIEF HAD BECOME DISCONNECTED FROM THE GRAFT ATTACHMENT AND WAS SLIGHTLY TILTED. THE SEALED OUTFLOW GRAFT, MEASURING APPROXIMATELY 4.5¿ IN LENGTH, WAS RETURNED UNATTACHED FROM THE OUTLET ELBOW. THE OUTFLOW GRAFT BEND RELIEF WAS RETURNED UNSEATED FROM THE GRAFT ATTACHMENT. THE TABS OF THE OUTFLOW GRAFT BEND RELIEF DID NOT APPEAR TO BE BENT OR MANIPULATED. THE HARDWARE OF THE OUTFLOW GRAFT BEND RELIEF WAS PROPERLY MATED WITH AND DISENGAGED FROM THE GRAFT ATTACHMENT OF THE OUTFLOW GRAFT. THE OUTFLOW GRAFT BEND RELIEF WAS FREE OF DISTORTION. AN EXAMINATION OF THE OUTFLOW GRAFT REVEALED A HOLE IN THE GRAFT CONDUIT ADJACENT TO THE GRAFT ATTACHMENT. THE GRAFT ALSO APPEARED TO BE KINKED IN THIS AREA. THE HOLE WAS LIKELY CAUSED BY THE ABRASION AGAINST ONE OF THE METAL CLIPS OF THE BEND RELIEF. THORATEC ISSUED A MEDICAL DEVICE CORRECTION NOTICE ON (B)(6) 2012 OUTLINING THE DESCRIPTION OF THE PROBLEM, SYMPTOMS AND RECOMMENDED IMMEDIATE AND PREVENTIVE ACTIONS AND A CORRECTIVE ACTION HAS SINCE BEEN IMPLEMENTED TO ADDRESS THE ISSUE. THE REPORT OF SUSPECTED THROMBUS CAN ALSO BE CONFIRMED. EXAMINATION OF THE BLOOD TUBE/ROTOR INLET SECTION REVEALED A THIN THROMBUS RING ADHERED TO THE INLET BEARING BALL. THE DEPOSITION APPEARED TO BE IN THE EARLY STAGES OF LAMINATED LAYERING, WHICH SUGGESTS THAT THE FORMATION WAS LIKELY PRESENT WHILE THE PUMP WAS OPERATING. AN EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE THROMBUS. A SAMPLE OF THE THROMBUS FOUND ON THE INLET BEARING BALL, WAS SUBMITTED TO AN OUTSIDE LAB FOR HISTOPATHOLOGY ANALYSIS. THE SAMPLE WAS CONSISTENT WITH A FIBRIN CLOT WITH NO HOST CELL INFILTRATION, NO EVIDENCE OF ORGANIZATION BY FIBROBLASTS, AND NO EVIDENCE OF COLLAGEN DEPOSITION. ALTHOUGH THE CLOT WAS ONE HOMOGENOUS MATERIAL, THE CLOT WAS INTERPRETED AS SERUM PROTEINS AND MIXED WITH FIBRIN. SOME OF THE RED COLORATION MAY ALSO HAVE BEEN DUE TO RED BLOOD CELL (RBC) BREAKDOWN PRODUCTS. THE GRANULARITY AT THE EDGES IN SOME LOCATIONS WAS EITHER FRAGMENTED MATERIAL OF THE HOMOGENOUS CLOT OR IT POSSIBLY MAY HAVE REPRESENTED RESIDUAL PLATELETS. THE LACK OF STRUCTURE SUGGESTED AN ORIGIN DATING AT LEAST 72 HOURS PRIOR TO EXPLANTATION. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: LVAD DEVICE WITH CURVED DISLODGMENT OF THE OUTFLOW BEND RELIEF AND PUMP THROMBUS. ADDITIONAL INFORMATION ALSO INCLUDED INDICATED: SIGNS OR SYMPTOMS: ELEVATED LDH. INTRAVENOUS ANTICOAGULATION: YES. THROMBUS EVENT CONFIRMED: NO. PATIENT OUTCOME: EXCHANGE: YES. DEVICE MALFUNCTION CAUSATIVE FACTOR: NO CAUSE IDENTIFIED: YES.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2014, DUE TO SUSPECTED PUMP THROMBOSIS SECONDARY TO A DISCONNECTED OUTFLOW GRAFT BEND RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378055 HEARTSTART II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 94252

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention