BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO GRAFT

    MDR report key: 5151279 · Received October 15, 2015

    Report

    Report Number
    1063481-2015-00260
    Event Type
    Death
    Date Received
    October 15, 2015
    Date of Event
    May 25, 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 HERO GRAFT WAS IMPLANTED ON (B)(6) 2009. ON (B)(6) 2009 THE PATIENT PRESENTED WITH A GRAFT THROMBOSIS AND A PERCUTANEOUS THROMBECTOMY WAS DONE ON (B)(6) 2009 DURING WHICH FLOW WAS RESTORED. AN OPEN THROMBECTOMY WAS DONE ON (B)(6) 2009, AGAIN FLOW WAS SUCCESSFULLY RESTORED. ON (B)(6) 2009 THE PATIENT WAS TREATED FOR A DIABETIC WOUND ON HIS RIGHT FOOT. ON (B)(6) 2009 THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. ON (B)(6) 2010 THE PATIENT PRESENTED WITH A GRAFT THROMBOSIS AND A PERCUTANEOUS THROMBECTOMY WAS DONE ON (B)(6) 2010 DURING WHICH FLOW WAS RESTORED. ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FEVER AND HYPOTENSION. SHE WAS TREATED WITH PRESSORS IN THE ER AND TRANSFERRED TO THE ICU. SHE WAS EVALUATED BY ORTHOPEDIC SURGERY AND VASCULAR SURGERY FOR A RIGHT FOOT ULCER. SHE WAS ALSO FOUND TO HAVE A STEMI (NON-ST ELEVATED MYOCARDIAL INFARCTION). THE PATIENT'S MYOCARDIAL INFARCTION WAS TREATED WITH A HEPARIN DRIP, ASPIRIN, AND PLAVIX. AT APPROXIMATELY 2200 HOURS, THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST. ATTEMPTS TO RESUSCITATE HER WERE UNSUCCESSFUL AND SHE WAS PRONOUNCED DEAD AT 2230 HOURS. THE MANUFACTURING RECORDS FOR LOTS 0000344, 0000239, 0000224, AND 0000203 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. THE 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 AN INTERNAL JUGULAR VEIN. THE FIRST DATE OF CANNULATION IS UNKNOWN BUT OCCURRED AT SOME POINT IN 2009. THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS INCLUDE THE FOLLOWING: MULTIPLE FAILED ATTEMPTS AT DIALYSIS ACCESS, HYPERTENSION, CORONARY ARTERY DISEASE (CAD), DIABETES MELLITUS TYPE 2, HISTORY OF EXTREMITY THROMBOSIS, DYSLIPIDEMIA, ASTHMA, PERIPHERAL VASCULAR DISEASE (PVD), AND END STAGE RENAL DISEASE (ESRD). THE PATIENT ALSO HAD A HISTORY OF COUMADIN/WARFARIN AND PLAVIX USE. THE PATIENT HAD THREE THROMBOSIS EVENTS WHICH REQUIRED SURGICAL INTERVENTION. THE PATIENT HAD TWO PERCUTANEOUS THROMBECTOMIES FOR A FULLY OCCLUDED HERO GRAFT ON (B)(6) 2009 AND ON (B)(6) 2010 AND ONE OPEN THROMBECTOMY IN (B)(6) 2009. PARTIAL STENOSIS OR FULL OCCLUSION OF THE PROSTHESIS OR VASCULATURE IS LISTED AS A POTENTIAL COMPLICATION IN THE HERO GRAFT INSTRUCTIONS FOR USE (IFU). HYPERCOAGULABILITY STATES OR INADEQUATELY MAINTAINED ANTICOAGULATION THERAPY COULD CONTRIBUTE TO AN INCREASED RISK OF THROMBOSIS. PRECAUTIONS REGARDING INADEQUATE ANTICOAGULATION ARE PROVIDED IN THE IFU. AS PREVIOUSLY STATED, THE PATIENT HAD A PRIOR HISTORY OF THROMBOSIS AND WAS ON COUMADIN AND PLAVIX (PRESCRIPTION COMPLIANCE IS UNKNOWN). THE SPECIFIC RELATIONSHIP BETWEEN THE THROMBOSIS/OCCLUSION EVENTS AND THE HERO GRAFT WAS NOT DOCUMENTED. THE PATIENT'S HISTORY OF MULTIPLE PRIOR THROMBOSES SUGGESTS A HYPERCOAGULABLE STATE PLACE THE PATIENT AT INCREASED RISK FOR THROMBOSIS EVENTS. THE PATIENT HAD MULTIPLE DOCUMENTED ISSUES WITH A NON-HEALING DIABETIC FOOT WOUND/ULCER THAT REQUIRED SURGICAL INTERVENTION FOR DEBRIDEMENT. THIS ISSUE HAS NO RELATIONSHIP TO HERO GRAFT BUT IS A RESULT OF THE PATIENT'S HISTORY OF TYPE II DIABETES. THE PATIENT HAD MULTIPLE DOCUMENTED CARDIAC ISSUES. THERE WERE TWO STEMI EVENTS AFTER HERO GRAFT IMPLANTATION; THERE WAS ALSO A NOTE OF CHEST PAIN ON (B)(6) 2010 (EKG FROM THAT VISIT REPORTED NO CHANGE FROM PRIOR TEST). ON (B)(6) 2009 THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND ASSOCIATED COUGH AND PRODUCTIVE SPUTUM, AS WELL AS CHEST TIGHTNESS. SHE WAS DIAGNOSED WITH NONSTEMI WITH THREE-VESSEL CAD. SHE UNDERWENT "HIGH RISK PCI" AND A DRUG-ELUTING STENT WAS PLACED TO THE LEFT CIRCUMFLEX AND ANOTHER TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROCEDURE WAS COMPLICATED BY HYPOTENSION (REQUIRING PRESSORS), HYPERCARBIA (CAUSING RESPIRATORY FAILURE), AND BRADYCARDIA REQUIRING A TEMPORARY PACEMAKER. THE PATIENT ALSO HAD ALTERED MENTAL STATUS, WHICH IMPROVED OVER THE COURSE OF THE ADMISSION. SHE WAS GIVEN DUAL ANTIPLATELET THERAPY (ASPIRIN/PLAVIX) AND SECONDARY THERAPY OF "ARB, BETA BLOCKER, AND STATIN." DURING THIS VISIT ON (B)(6) SHE WAS ALSO DOCUMENTED TO HAVE PULMONARY EDEMA (RELIEVED BY DIALYSIS), DYSPHAGIA (CONCERN FOR ASPIRATION - NOT CONFIRMED), AND WORSENING ANEMIA (RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS ON (B)(6)). ON (B)(6) 2010 THE PATIENT WAS ADMITTED WITH FEVER AND HYPOTENSION. SHE WAS AGAIN DIAGNOSED WITH NONSTEMI AND WAS TREATED WITH A HEPARIN DRIP, ASPIRIN, AND PLAVIX; PRESSORS WERE ALSO REQUIRED FOR BLOOD PRESSURE MAINTENANCE. THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA) CARDIAC ARREST AND CODED; RESUSCITATION EFFORTS WERE UNSUCCESSFUL. THERE WAS NO DOCUMENTED RELATIONSHIP BETWEEN THE HERO GRAFT AND ANY OF THE AFOREMENTIONED CARDIAC EVENTS (OR ASSOCIATED SYMPTOMS); CONSIDERING THE KNOWN PATIENT HISTORY, THE PATIENT WAS AT INCREASED RISK FOR CARDIAC EVENTS. THE PATIENT DIED ON (B)(6) 2015. THERE WAS NO DOCUMENTED RELATIONSHIP BETWEEN THE HERO GRAFT AND THE PATIENT'S 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 HERO GRAFT WAS IMPLANTED ON (B)(6) 2009. ON (B)(6) 2009 THE PATIENT PRESENTED WITH A GRAFT THROMBOSIS AND A PERCUTANEOUS THROMBECTOMY WAS DONE ON (B)(6) 2009 DURING WHICH FLOW WAS RESTORED. AN OPEN THROMBECTOMY WAS DONE ON (B)(6) 2009, AGAIN FLOW WAS SUCCESSFULLY RESTORED. ON (B)(6) 2009 THE PATIENT WAS TREATED FOR A DIABETIC WOUND ON HIS RIGHT FOOT. ON (B)(6) 2009 THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. ON (B)(6) 2010 THE PATIENT PRESENTED WITH A GRAFT THROMBOSIS AND A PERCUTANEOUS THROMBECTOMY WAS DONE ON (B)(6) 2010 DURING WHICH FLOW WAS RESTORED. ON (B)(6) 2010 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FEVER AND HYPOTENSION. SHE WAS TREATED WITH PRESSORS IN THE ER AND TRANSFERRED TO THE ICU. SHE WAS EVALUATED BY ORTHOPEDIC SURGERY AND VASCULAR SURGERY FOR A RIGHT FOOT ULCER. SHE WAS ALSO FOUND TO HAVE A STEMI (NON-ST ELEVATED MYOCARDIAL INFARCTION). THE PATIENT'S MYOCARDIAL INFARCTION WAS TREATED WITH A HEPARIN DRIP, ASPIRIN, AND PLAVIX. AT APPROXIMATELY 2200 HOURS, THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST. ATTEMPTS TO RESUSCITATE HER WERE UNSUCCESSFUL AND SHE WAS PRONOUNCED DEAD AT 2230 HOURS.

    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)(6). 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
    684237 HERO GRAFT VASCULAR GRAFT DSY CRYOLIFE, INC. HERO 4001 0000344

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death