BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO GRAFT

    MDR report key: 5151259 · Received October 15, 2015

    Report

    Report Number
    1063481-2015-00261
    Event Type
    Death
    Date Received
    October 15, 2015
    Date of Event
    April 8, 2009
    Report Date
    September 25, 2015
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K124039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A HERO GRAFT IMPLANTED ON 03/30/2009 AND SUFFERED A MAJOR GI (GASTROINTESTINAL) BLEED ON (B)(6) 2009 AND THEN DIED ON (B)(6) 2009. THE SCOPE OF THE INVESTIGATION WILL INCLUDE BOTH HERO 1001 AND 1002 COMPONENTS, BUT WILL BE REPORTED UNDER HERO 1001. THE HERO GRAFT WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATIONS ON (B)(6) 2009. ON (B)(6) 2009 THE PATIENT WAS STARTED ON ANTICOAGULATION THERAPY AND DEVELOPED HEMATEMESIS. AN EGD (ESOPHAGOGASTRODUODENOSCOPY) SHOWED MULTIPLE GASTRIC ULCERS. THE BLEEDING WAS EVENTUALLY STABILIZED AND HE WAS TREATED SUPPORTIVELY WITH FLUID REPLACEMENT AND BLOOD PRODUCTS. AS THE HERO GRAFT REQUIRES ANTICOAGULATION, THE PATIENT WAS CAUTIOUSLY STARTED BACK ON HEPARIN AND EVENTUALLY PLAVIX. THE PATIENT REMAINED STABLE FOR FOUR DAYS BUT SUDDENLY DEVELOPED MASSIVE HEMATEMESIS DURING DIALYSIS ON (B)(6) 2009. HE WAS EMERGENTLY TRANSFERRED TO THE MICU (MEDICAL INTENSIVE CARE UNIT) AND WAS RESUSCITATED AGGRESSIVELY. A REPEAT EGD SHOWED A LARGE POOL OF BLOOD AND PREVIOUSLY SEEN GASTRIC ULCERS BLEEDING AGAIN. INTERVENTIONAL RADIOLOGY EMBOLIZED THE GASTRIC AND GASTRODUODENAL ARTERY. THE BLEEDING AGAIN STABILIZED BUT THE PATIENT'S BLOOD PRESSURE DROPPED REQUIRING THREE VASOPRESSORS ON (B)(6) 2009. ON (B)(6) 2009 THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP AND ACIDOSIS WORSENED. HE CODED THREE TIMES, THE LAST RESUSCITATION ATTEMPT WAS UNSUCCESSFUL AND THE PATIENT WAS PRONOUNCED DEAD AT 8:00PM. THE CAUSE OF DEATH IS LISTED AS SEVERE ACIDOSIS AND HYPOTENSION SECONDARY TO MASSIVE GI HEMORRHAGE. THE MANUFACTURING RECORDS FOR LOTS 0000368, 0000367, 0000239, 0000247, AND 0000224 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. THIS PATIENT WAS IMPLANTED WITH A HERO GRAFT ON (B)(6) 2009. THE GRAFT WAS IMPLANTED WITH A BRACHIAL ARTERIAL ANASTOMOSIS AND THE VENOUS ACCESS POINT WAS THE SUPERIOR VENA CAVA (SVC). THE FIRST DATE OF CANNULATION IS NOT DOCUMENTED, AS THE PATIENT DIED BEFORE THE GRAFT INCORPORATION PERIOD ENDED. THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS INCLUDE THE FOLLOWING: "SEVERE END-STAGE VASCULAR ACCESS COMPLICATIONS," A FIBROSING CONDITION RELATED TO PREVIOUS GADOLINIUM EXPOSURE, A HYPERCOAGULABLE STATE WITH ELEVATED HOMOCYSTEINE, HISTORY OF MULTIPLE DEEP VEIN THROMBOSIS (DVT) EVENTS, AND END STAGE RENAL DISEASE. THE PATIENT WAS ADMITTED FOR HERO GRAFT IMPLANT AND SUBSEQUENTLY DEVELOPED HEMATEMESIS ON (B)(6) 2009; AN EGD REVEALED MULTIPLE GASTRIC ULCERS. THE PATIENT WAS TREATED AND STABILIZED BUT ON (B)(6) 2009 DEVELOPED HEMATEMESIS AGAIN. HE REQUIRED 13 UNITS OF PACKED RED BLOOD CELLS; THE GASTRIC AND GASTRODUODENAL ARTERY WAS EMBOLIZED AT THIS POINT. ON (B)(6) 2009 THE PATIENT'S BLOOD PRESSURE DROPPED, WHICH REQUIRED VASOPRESSORS. THE NEXT DAY THE PATIENT'S BLOOD PRESSURE DROPPED BELOW BASELINE AND HE CONTINUED TO HAVE WORSENING ACIDOSIS. DESPITE FULL RESUSCITATION ATTEMPTS, THE PATIENT DIED ON (B)(6) 2009. THE OFFICIAL CAUSE OF DEATH WAS DOCUMENTED AS "SEVERE ACIDOSIS AND HYPOTENSION SECONDARY TO A MASSIVE GI HEMORRHAGE." THE HERO INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING AS A POTENTIAL INTRAOPERATIVE AND POST-OPERATIVE COMPLICATION. IN THIS CASE THE PATIENT'S BLOOD LOSS RESULTED FROM INTERNAL BLEEDING AND RESULTING HEMATEMESIS POST HERO GRAFT IMPLANT, FOR WHICH THE PATIENT WAS TREATED WITH PLAVIX TO PREVENT BLOOD CLOTTING; THE PATIENT HAD AN ESTABLISHED HISTORY OF DVT AND WAS DOCUMENTED TO HAVE HYPERCOAGULABLE ISSUES. THE HERO GRAFT DID NOT HAVE DIRECT INVOLVEMENT IN THE PATIENT'S CAUSE OF DEATH; THE REQUIRED POST-OP MEDICATION COMPLICATED THE PATIENT'S RECOVERY DUE TO THE PATIENT'S EXISTING CO-MORBIDITIES. HOWEVER, THE HERO IFU LISTS DEATH AS A POTENTIAL INTRAOPERATIVE AND POST-OPERATIVE COMPLICATION. THERE WAS NO DOCUMENTED DIRECT RELATIONSHIP BETWEEN THE HERO GRAFT AND THE PATIENT'S GI HEMORRHAGE OR DEATH.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE PATIENT HAD A HERO GRAFT IMPLANTED ON (B)(6) 2009 AND SUFFERED A MAJOR GI (GASTROINTESTINAL) BLEED ON (B)(6) 2009 AND THEN DIED ON (B)(6) 2009. THE SCOPE OF THE INVESTIGATION WILL INCLUDE BOTH HERO 1001 AND 1002 COMPONENTS, BUT WILL BE REPORTED UNDER HERO 1001.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, THE CLINICAL STUDY COORDINATOR HAS ENTERED 55 INFORMED CONSENT FORMS IN THE CLINICAL STUDY FOR HERO GRAFT PATIENTS WHO "HAVE PASSED AWAY AND WERE RECRUITED WITH A DECEDENT WAIVERS [INCLUSION INTO THE STUDY POST MORTEM]". DATA WILL BE REVIEWED AS THE COORDINATORS ENTER THE CASE REPORT FORMS (CRFS) ASSOCIATED WITH THESE PATIENTS. ADDITIONAL INFORMATION IS PENDING. THIS INVESTIGATION IS FOR PATIENT (B)(4). THE SCOPE OF THE INVESTIGATION WILL INCLUDE BOTH HERO 1001 AND 1002 COMPONENTS, BUT WILL BE REPORTED UNDER HERO 1001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683988 HERO GRAFT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 1001 0000368

    Patients

    Seq Age Sex Outcome Treatment
    1 Death