BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2396937 · Received December 21, 2011

    Report

    Report Number
    1820334-2011-00722
    Event Type
    Death
    Date Received
    December 21, 2011
    Date of Event
    November 17, 2011
    Report Date
    December 1, 2011
    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

    (B)(4). ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, F/U GUIDELINES. BY REPORT, THE PT WAS NOT SUITABLE FOR EVAR. CLINICAL REVIEW OF REPORTED TYPE IV ENDOLEAKS HAS REVEALED THAT A TYPE IV IS POSSIBLE WITH DIRECT INJECTION AND AGGRESSIVE ANTICOAGULATION WHILE LIMITING OR BLOCKING OUTFLOW. IN THESE SAME EVENTS THE ENDOLEAK IS RESOLVED AT F/U. BASED ON THE INFO PROVIDED, IT IS POSSIBLE THAT THERE WERE MULTIPLE ENDOLEAKS THAT MAY HAVE MADE IDENTIFICATION OF EACH ENDOLEAK DIFFICULT. A TYPE II ENDOLEAK WAS DETECTED 10 DAYS AFTER REPAIR AND LIKELY CONTRIBUTED TO VESSEL RUPTURE. PT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAKS AND VESSEL RUPTURE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA). THE RISK ASSOCIATED WITH THIS FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A PT UNDERWENT AAA REPAIR. THE PT HAD AAA AND TAAA. BLOOD VESSEL PROSTHESIS IMPLANTATION (ELEPHANT TRUNK) WAS CONDUCTED IN CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY AND RENAL ARTERY FOR TAAA SIX MONTHS AGO. THE PT WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR. ACT: AROUND 220-230. ON (B)(6) 2011: ZENITH WAS PLACED FOR AAA FROM BLOOD VESSEL PROSTHESIS SITE. MAIN BODY WAS DEPLOYED WITH FOLLOWING THE PROCEDURE, THEN CONFIRMATORY ANGIOGRAPHY CONFIRMED LEAKAGE AT PROXIMAL SITE AND AROUND CONTRALATERAL LIMB TICK MARK. RE-BALLOONING WAS PERFORMED WITH CODA IN PROXIMAL SITE AND WITH ANOTHER MFR'S BALLOON IN OVERLAPPED POSITION OF CONTRALATERAL LIMB. THEN, CONFIRMATORY ANGIOGRAPHY SHOWED LEAKAGE WHICH APPEARED TO BE FROM PROXIMAL SITE. THE PHYSICIAN OCCLUDED RIGHT AND LEFT LIMBS WITH BALLOON TO TAKE RETROGRADE ANGIOGRAPHY, THEN HE CONFIRMED THERE WAS NO PROXIMAL TYPE I ENDOLEAK OR TYPE III ENDOLEAK. ANGIOGRAPHY WAS TAKEN IN MAIN BODY WITH PIG TAIL CATHETER, THEN ENDOLEAK WAS CONFIRMED. THE PHYSICIAN JUDGED IT AS TYPE IV ENDOLEAK AT PROXIMAL SITE OF BLOOD VESSEL PROSTHESIS AND THE PROCEDURE WAS COMPLETED. (#1820334-2011-00721). ON (B)(6) 2011: THE PT WENT INTO THE HOSPITAL WARD. VERTEBRAL BODY PARALYSIS WAS CONFIRMED. ON (B)(6) 2011: VERTEBRAL BODY PARALYSIS WAS IMPROVED. ON (B)(6) 2011: THE PT COMPLAINED HEADACHE WHEN THE PHYSICIAN WENT THE ROUND IN THE EARLY-EVENING. ON (B)(6) 2011: 16:00 - CARDIAC ARREST. THOUGH CARDIO PULMONARY RESUSCITATION WAS CONDUCTED, HEMOGLOBIN LEVEL FELL. BLOATED STOMACH WAS CONFIRMED AND REDUCTION OF BLOOD PRESSURE DOWN TO 30 WAS DETECTED. BLOOD VESSEL PROSTHESIS IMPLANTATION WAS CONDUCTED BY URGENT LAPAROTOMY. THE PHYSICIAN FOUND THROMBUS IN RETROPERITONEUM. TYPE II ENDOLEAK WAS CONFIRMED NEAR LUMBAR ARTERY, BUT TYPE I WAS NOT DETECTED. CONTRALATERAL LIMB WAS VISIBLE FROM RUPTURED POSITION. (#1820334-2011-00722). ADD'L INFO: SINCE DETERIORATION OF RENAL FUNCTION WAS OBSERVED TO THE PT, THE PHYSICIAN DID NOT CONDUCT CT POSITIVELY AND PLANNED IT TWO WEEKS AFTER THE PROCEDURE. THE PT WAS CARED WITH BLOOD PRESSURE AROUND 130 DUE TO VERTEBRAL BODY PARALYSIS. WHETHER TYPE IV REMAINED OR NOT AFTER THE PROCEDURE IS UNK. RUPTURED POSITION IS A CONTRALATERAL LIMB PLACEMENT PART. THE LIMB WAS VISIBLE FROM THE RUPTURED POINT. THE CAUSE OF RUPTURE, ENDOLEAK OR REPETITIVE BALLOONING, IS UNK. THE PT DIED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA F2674386

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death