BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1558654 · Received December 8, 2009

    Report

    Report Number
    1820334-2009-00699
    Event Type
    Death
    Date Received
    December 8, 2009
    Date of Event
    October 28, 2009
    Report Date
    November 9, 2009
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NUMEROUS VERIFICATION AND VALIDATION ACTIVITIES PERFORMED THAT HAVE SHOWN THE DEVICE MEETS DESIGN INPUT REQUIREMENTS AND USER NEEDS WHEN USED AS THE IFU (INSTRUCTIONS FOR USE) INDICATES. IN ADDITION, EACH DEVICE IS SHIPPED WITH AN IFU THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNING AND PRECAUTIONS, AND CONTRAINDICATIONS. THE IFU SPECIFICALLY STATES; VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. UNLESS MEDICALLY INDICATED, DO NOT DEPLOY THE ZENITH AAA ENDOVASCULAR GRAFT IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES. VESSEL OCCLUSION MAY OCCUR. TAKE CARE DURING MANIPULATION OF CATHETERS, WIRES AND SHEATHS WITHIN AN ANEURYSM. SIGNIFICANT DISTURBANCES MAY DISLODGE FRAGMENTS OF THROMBUS WHICH CAN CAUSE DISTAL EMBOLIZATION. NO IMAGES WERE RETURNED, WHICH MADE A DETERMINATION OF THE ROOT CAUSE DIFFICULT. THE INFORMATION PROVIDED STATED THAT THE PATIENT HAD A NUMBER OF PREEXISTING CONDITIONS, INCLUDING AN ARTIFICIAL VESSEL OF THE DESCENDING THORACIC AORTA. IT IS POSSIBLE THAT DURING THE REPAIR OF THE THORACIC AORTA SOME OR ALL OF THE VERTEBRAL ARTERIES WERE COVERED. COLLATERAL ARTERIES WOULD HAVE BEEN SUPPLYING THE NECESSARY BLOOD FLOW. THE COLLATERAL ARTERIES COULD HAVE BEEN COVERED DURING THE COMPLAINT EVENT. THIS WOULD HAVE RESULTED IN SPINAL CORD ISCHEMIA AND PARAPLEGIA. THE COMPLAINT CORRESPONDENCE INDICATES THAT SPLENIC INFARCTION REVEALED AT TIME OF PARAPLEGIA. KIDNEY FAILURE OCCURRED APPROXIMATELY TWO DAYS LATER. SHAGGY AORTA (SEVERE ARTERIAL DEGENERATION OF THE AORTA, THE SURFACE OF WHICH IS EXTREMELY FRIABLE AND LIKELY TO CAUSE ATHEROEMBOLISM) WAS CONFIRMED IN THE PATIENT. THE PATIENT MOST LIKELY SUFFERED A MASSIVE (SHOWER) EMBOLIZATION, RESULTING IN MULTIPLE ORGAN FAILURE. WITHOUT IMAGES WE ARE UNABLE TO COMMENT ON THE PATIENT'S SUITABILITY FOR EVAR. WITH THE INFORMATION PROVIDED THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE COMPLAINT DEVICE RESULTED IN THE PARALYSIS AND DEATH OF THE PATIENT. AT THIS TIME WE CAN CONFIRM THAT THE PATIENT SUFFERED AN ADVERSE PHYSIOLOGICAL RESPONSE AFTER THE PLACEMENT OF THE COMPLAINT DEVICE. THE RESPONSE WAS MOST LIKELY THE RESULT OF PREEXISTING AND COMPOUNDING CONDITIONS RELATED TO THE PATIENT'S ANATOMY. WE WILL NOTIFY THE APPROPRIATE PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED AND NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE PATIENT HAD ARTIFICIAL VESSEL PLACEMENT FOR DESCENDING THORACIC AORTA. DDD PACE MAKER PLACEMENT, HIGH BLOOD PRESSURE (ON MEDICATION). SHAGGY AORTA WAS CONFIRMED IN THE PATIENT. CREATININE LEVEL WAS 1.51MG/DL. IN 2009, AFTER EMBOLIZING THE LEFT INTERNAL ILIAC ARTERY WITH COILS, ZENITH AAA ENDOVASCULAR GRAFTS WERE PLACED AS LABELED. THE MAIN BODY WAS PLACED WITH LEFT APPROACH. AFTER THE PATIENT WOKE UP FROM ANESTHESIA, HE WAS TAKEN TO THE ICU. THE FOLLOWING DAY, THE BLOOD INTO THE VERTEBRAL ARTERY WAS NOT CONFIRMED AND PARAPLEGIA OCCURRED. ALSO CT REVEALED SPLENIC INFARCTION. THE PHYSICIAN STARTED CSF (CEREBROSPINAL FLUID) DRAINAGE AND ADMINISTRATION OF NALOXONE AND STEROID. IN THREE DAYS, THE PHYSICIAN HAD CONTINUED CSF DRAINAGE AND ADMINISTRATION OF NALOXONE AND STEROID ALL FOR ONE DAY, BUT THE PATIENT WAS NOT IMPROVED (THE PHYSICIAN CONTACTED WITH OTHER FACILITY'S PHYSICIANS AND CONFIRMED THAT THE PERFORMED TREATMENT WAS CORRECT). CHDF (CONTINUOUS HEMODIAFILTRATION) WAS PERFORMED SINCE THE LEVELS OF GOT, GPT, LDH, AND CPK WENT UP AND KIDNEY FAILURE ALSO OCCURRED. AFTER STARTING CHDF, DIURESIS WAS CONFIRMED AND THE LEVELS OF GOT, GPT, LDH, AND CPK BECAME STABLE. THE PATIENT WAS IN A LULL. THE NEXT DAY (PAST 0:00), RESPIRATORY STATUS WORSENED AND ENDOTRACHEAL INTUBATION WAS PERFORMED. ANURIA WAS CONFIRMED AND ALSO THE LEVELS OF GOT, GPT, LDH, AND CPK WENT UP AGAIN. POTASSIUM EXCRETION WITH CHDF WAS UNABLE TO BE MAINTAINED. AT (22:00), THE PATIENT PASSED AWAY DUE TO MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA F2384068

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| R