BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 4106557 · Received September 4, 2014

    Report

    Report Number
    1820334-2014-00431
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    December 11, 2013
    Report Date
    August 14, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST WITH THIS INVESTIGATION. A REVIEW OF COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL DOCUMENTATION, SPECIFICATIONS AND TRENDS WAS CONDUCTED. BASED ON THE INFORMATION PROVIDED, A PATIENT IN THE SPIRAL-Z REGISTRY HAD A PROXIMAL TYPE 1 ENDOLEAK AT THE COMPLETION OF THE DEPLOYMENT PROCEDURE. THE PROXIMAL NECK WAS INVERTED FUNNEL SHAPE WITH NO PLAQUE/THROMBUS. AT 110 DAYS POST PROCEDURE, THE ENDOLEAK REMAINED. AT 112 DAYS POST PROCEDURE, A BARE STENT WAS PLACED TO TREAT THE ENDOLEAK. NO INFORMATION REGARDING OUTCOME WAS PROVIDED. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS DEMONSTRATING THAT THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. SPECIFICALLY, DESIGN VERIFICATION TESTING INCLUDED WATER PERMEABILITY TESTING, MIGRATION RESISTANCE TESTING, AND RADIAL FORCE TESTING. THE RESULTS MET THE ACCEPTANCE CRITERIA. THE IFU PROVIDES INSTRUCTIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS REGARDING THE APPROPRIATE METHOD OF USE. SPECIFICALLY, IT STATES "ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING AN ENLARGING ANEURYSM, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. PATIENT'S EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES." ADDITIONALLY, IT STATES "KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION (>60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR >45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (<1 5 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC LENGTH); AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IN THE PRESENCE OF ANATOMICAL LIMITATIONS, A LONGER NECK MAY BE REQUIRED TO OBTAIN ADEQUATE SEALING AND FIXATION. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE ATTACHMENT AND SEALING AT THE FIXATION SITES. NECKS EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK." NO LOT NUMBER WAS PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. THE IFU CAUTIONS THAT PATIENTS HAVING AN INVERTED FUNNEL SHAPED NECK MAY BE MORE CONDUCIVE TO ENDOLEAKS. NO IMAGING WAS RETURNED, AND NO LOT NUMBER WAS PROVIDED. IT IS POSSIBLE THAT PATIENT ANATOMY CONTRIBUTED TO THIS EVENT; HOWEVER, WITHOUT ADDITIONAL INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. THE RISK WAS ASSESSED USING QUALITY ENGINEERING RISK ASSESSMENT (QERA). THE RISK REMAINS ACCEPTABLE WITH INCLUSION OF THIS EVENT. NO ADDITIONAL RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS (B)(4)-YEAR-OLD FEMALE PATIENT IN THE (B)(4) UNDERWENT A SECONDARY INTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK ON (B)(6) 2013. (112 DAYS POST-PROCEDURE). THE PATIENT WAS TREATED ON (B)(6) 2013 FOR AN AORTOILIAC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 5.2CM. THE PROXIMAL NECK HAD INVERTED FUNNEL SHAPE WITH NO PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MODERATE TORTUOSITY, MILD OCCLUSIVE DISEASE AND MODERATE CALCIFICATION. THE RIGHT ILIAC ARTERY HAD MODERATE TORTUOSITY, MILD OCCLUSIVE DISEASE, AND MODERATE CALCIFICATION. THE PATIENT RECEIVED A MAIN-BODY DEVICE, A LEFT ILIAC LEG, A RIGHT ILIAC LEG, AND A LEFT ILIAC LEG EXTENSION. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER DEVICES WERE USED AND NO OTHER PROCEDURES WERE PERFORMED. A MOLDING BALLOON WAS USED, BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATIENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A PROXIMAL TYPE I ENDOLEAK WAS NOTED. ON (B)(6) 2013 (110 DAYS POST-PROCEDURE), THE PATIENT WAS NOTED TO HAVE AN ANEURYSM LEAK. ON (B)(6) 2013 (112 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT PLACEMENT OF A BARE STENT FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2014 (159 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA. NO OTHER INFO REGARDING THE EVENT IS AVAILABLE.

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED MARCH 31, 2015; PT DIED ON (B)(6) 2014; (1820334-2014-00432).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539808 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| O| R