BEUDAMED
    FDA Adverse Event Death Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4640920 · Received March 26, 2015

    Report

    Report Number
    3008788191-2015-00009
    Event Type
    Death
    Date Received
    March 26, 2015
    Date of Event
    February 5, 2015
    Report Date
    March 25, 2015
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVAL COMPLETED. LOT HISTORY RECORD REVIEW CONDUCTED. CAPA (B)(4) INITIATED. THE DEVICE HAS NOT YET BEEN RETURNED TO BE MFR FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6), PT (B)(6) UNDERWENT A STAND ALONE LAA OCCLUSION IN MINI THORACOTOMY UNDER DIRECT VISUALIZATION USING TIGERPAW 9C. VISIBILITY OF THE LAA WAS OPTIMAL; STRAIGHT AFTER THE IMPLANT, A LACERATION OCCURRED IN THE ATRIUM (NOT IN THE LAA) AT THE JUNCTION WITH IMPLANTED DEVICE. THE DEVICE APPEARED CORRECTLY PLACED AND THE EXCLUSION OF THE LAA WAS TOTAL. THE DOCTORS TRIED TO SUTURE THE LACERATION, BUT DUE TO THE IMPOSSIBILITY OF ACHIEVING A STOPPAGE OF THE BLEEDING, THEY DECIDED TO CONVERT THE SURGERY INTO OPEN CHEST SURGERY. PT WAS PUT ON PUMP AND THEY CLOSED THE LACERATION FROM THE INSIDE OF THE ATRIUM, ALSO REINFORCING THE LAA OCCLUSION WITH A SUTURE. AFTER SEVERAL DAYS IN THE ICU, THE PT DIED ON THE (B)(6) POST-OP DAY DUE TO A SEPSIS CONNECTED WITH THE HAEMORRHAGIC SHOCK OCCURRED DURING THE PROCEDURE. ACCORDING TO THE CARDIAC SURGEON, (B)(6) THE APPLICATION OF TIGERPAW CREATED AN UNUSUAL TENSION AT THE ATRIUM, CAUSING THE LACERATION AND ALL SUBSEQUENT EVENTS. A (B)(6) MALE REFERRED TO SURGERY FOR A LAA OCCLUSION STANDALONE BECAUSE OF SEVERAL EVENTS OF INTESTINAL BLEEDING DUE TO ANTICOAGULATION AGENTS. PT HAD PAROXYSMAL AFIB WITH GOOD RATE CONTROL. HE ALSO HAD MODERATE AORTIC INSUFFICIENCY AND MILD MITRAL INSUFFICIENCY. EF 40%. SURGERY PERFORMED ON A MINI LEFT THORACOTOMY. VERY GOOD EXPOSURE. DEVICE WAS APPLIED AND DELIVERED WITH MINIMAL MANIPULATION. IMMEDIATELY AFTER APPLICATION A TEAR (2-3 MM) WAS NOTED ON THE LEFT ATRIAL ROOF ADJACENT (PARALLEL) TO THE TIGERPAW DEVICE. HE TRIED TO REPAIR THE TEAR WITH SUTURES UNSUCCESSFULLY AND THE TEAR BECAME BIGGER WITH SIGNIFICANT BLEEDING. PT BECAME HYPOTENSIVE. HE DECIDED IMMEDIATELY TO PERFORM A STERNOTOMY AND PROCEED TO START CENTRAL EXTRACORPOREAL CIRCULATION. CARDIOPLEGIC ARRESTED HEART. THE LEFT ATRIUM WAS ACCESSED TRANS-SEPTALLY. THE TEAR WAS SUCCESSFULLY REPAIRED WITH SUTURES. TIGERPAW REMAINED IN PLACE. IT WAS NOTED THAT THE DEVICE WAS DEPLOYED CORRECTLY AND THE LAA WAS COMPLETELY EXCLUDED. THE THICKNESS OF THE LAA WAS NORMAL. NO MEASUREMENT WAS PERFORMED. OVERALL THE PT WAS IN THE OPERATING ROOM FOR 6 HOURS. HE WAS THEN TRANSFERRED TO THE ICU IN GOOD HEMODYNAMIC CONDITION. THE PT WAS TRANSFUSED WITH 5 UNITS OF BLOOD. DURING THE ICU STAY THE PT BECAME SEPTIC. THE KIDNEY AND LIVER FUNCTION DETERIORATED AND THE PT EXPIRED AT THE 17TH POST-OPERATIVE DAY. THE SURGEON IS A VERY SKILLED SURGEON WITH EXTENSIVE EXPERIENCE IN MINIMALLY INVASIVE CARDIAC SURGERY. HE DEPLOYED MANY ATRICLIP DEVICES DURING OPEN AND MI SURGERIES. IT WAS HIS FIRST TIGERPAW DEPLOYMENT. OUR LOCAL REPRESENTATIVE RETRAINED HIM BEFORE THE PROCEDURE WITH A DEMO DEPLOYMENT. ACCORDING TO THE SURGEON, THE DEVICE FUNCTIONED AS EXPECTED. THE POSITION WAS ACCURATE. HE CAN'T EXPLAIN WHY THE TEAR OCCURRED. HE ASSUMES THE DEPLOYMENT CREATED AN AREA OF TENSION ON THE LEFT ATRIAL WALL WHERE THE TISSUE ULTIMATELY TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202511 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 0898M

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death