BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 8285534 · Received January 29, 2019

    Report

    Report Number
    1820334-2019-00264
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    December 27, 2018
    Report Date
    April 22, 2019
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002484327
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION/EVALUATION THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. IMAGING WAS NOT PROVIDED FOR REVIEW. A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED INCLUDING A REVIEW OF THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) REVEALED NO NON-CONFORMANCES WERE DETECTED FOR WO# 3902292 (ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY), FS3683460 (ZENITH FLEX AAA MAIN BODY), FS3597137 (ZENITH FLEX AAA MAIN BODY KIT), AND SUPPLIER LOT 1214329.1. COOK WAS UNABLE TO PERFORM A PHYSICAL EVALUATION OF THE COMPLAINT DEVICE AS THE PRODUCT WAS NOT RETURNED. PER FURTHER COMMUNICATION WITH THE USER FACILITY, THE PHYSICIAN HAS CHOSEN NOT TO PROVIDE IMAGING; THEREFORE, AN IMAGE REVIEW WAS UNABLE TO BE PERFORMED. THE IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: WARNINGS AND PRECAUTIONS ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING A LARGE 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. 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 CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP 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 (<15MM); AND INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15MM OF PROXIMAL AORTIC NECK 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. 4.4 DEVICE SELECTION STRICT ADHERENCE TO THE ZENITH FLEX AAA ENDOVASCULAR GRAFT IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLES 10.5.1 THROUGH 10.5.2). APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION DEVICE INFOLDING OR COMPRESSION 4.5 IMPLANT PROCEDURE INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. INADEQUATE FIXATION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT MAY RESULT IN INCREASED RISK OF MIGRATION OF THE STENT GRAFT. INCORRECT DEPLOYMENT OR MIGRATION OF THE ENDOPROSTHESIS MAY REQUIRE SURGICAL INTERVENTION. 12.3 ABDOMINAL RADIOGRAPHS THE FOLLOWING VIEWS ARE REQUIRED: FOUR FILMS: SUPINE-FRONTAL (AP), CROSS-TABLE LATERAL, 30 DEGREE LPO AND 30 DEGREE RPO VIEWS CENTERED ON UMBILICUS. RECORD THE TABLE-TO-FILM DISTANCE AND USE THE SAME DISTANCE AT EACH SUBSEQUENT EXAMINATION ENSURE ENTIRE DEVICE IS CAPTURED ON EACH SINGLE IMAGE FORMAT LENGTHWISE. IF THERE IS ANY CONCERN ABOUT THE DEVICE INTEGRITY (E.G. KINKING, STENT BREAKS, BARB SEPARATION, RELATIVE COMPONENT MIGRATION), IT IS RECOMMENDED TO USE MAGNIFIED VIEWS. THE ATTENDING PHYSICIAN SHOULD EVALUATE FILM FOR DEVICE INTEGRITY (ENTIRE DEVICE LENGTH INCLUDING COMPONENTS) USING 2-3X MAGNIFICATION VISUAL AID. 12.6 ADDITIONAL SURVEILLANCE AND TREATMENT ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ANEURYSMS WITH TYPE I ENDOLEAK ANEURYSMS WITH TYPE III ENDOLEAK ANEURYSM ENLARGEMENT, =5 MM OF MAXIMUM DIAMETER (REGARDLESS OF ENDOLEAK STATUS) MIGRATION INADEQUATE SEAL LENGTH CONSIDERATION FOR REINTERVENTION OR CONVERSION TO OPEN REPAIR SHOULD INCLUDE THE ATTENDING PHYSICIAN¿S ASSESSMENT OF AN INDIVIDUAL PATIENT¿S CO-MORBIDITIES, LIFE EXPECTANCY AND THE PATIENT¿S PERSONAL CHOICES. PATIENTS SHOULD BE COUNSELED THAT SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER BASED AND OPEN SURGICAL CONVERSION ARE POSSIBLE FOLLOWING ENDOGRAFT PLACEMENT. NEITHER IMAGING, PLANNING AND SIZING, NOR THE PHYSICAL PRODUCT WAS RETURNED FOR EVALUATION. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED. THERE IS NOT ENOUGH EVIDENCE TO IMPLICATE AND ISOLATE ONE CONTRIBUTING FACTOR OVER ANOTHER. HOWEVER, TAKEN INTO CONSIDERATION THAT THIS ADVERSE EVENT OCCURRED 5 YEARS (2156 DAYS) POST-PROCEDURE AND HAD NO COMPLICATIONS BEFOREHAND AND THAT IT WAS CONFIRMED THE PATIENT HAD MADE REGULAR FOLLOW-UP APPOINTMENTS WITH THE ORIGINAL PHYSICIAN WHO HAD INITIALLY IMPLANTED THE DEVICES, THE MOST LIKELY CONTRIBUTING FACTOR IS DUE TO DISEASE PROGRESSION IN REGARD TO THE PATIENT¿S ANATOMY. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGE IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZSLE-20-90-ZT LOT 3819572; ZSLE-20-39-ZT LOT 2793747. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES MIGRATED DISTALLY TOGETHER AND CAUSED AN ENDOLEAK THAT LED TO A RUPTURED AORTIC ANEURYSM AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY (IMA). THE DEVICES WERE ORIGINALLY IMPLANTED AT A DIFFERENT HOSPITAL ON (B)(6) 2013. THE SURGEON COMPLETED AN OPEN JUXTARENAL ANEURYSM REPAIR. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL. THE PATIENT DID ATTEND FOLLOW UP APPOINTMENTS AS RECENTLY AS (B)(6) 2018 WITH THE PHYSICIAN THAT INITIALLY IMPLANTED THE COMPLAINT DEVICES. THIS REPORT ADDRESSES THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-36-95, LOT 3902292) THAT MIGRATED DISTALLY. THE FOLLOWING REPORTS ARE RELATED IN REFERENCE AS THE TWO ADDITIONAL DEVICES WERE REPORTED TO MIGRATE DISTALLY AS WELL. 1820334-2019-00265 - (ZSLE-20-90-ZT, LOT 3819572); 1820334-2019-00266 - (ZSLE-20-39-ZT, LOT 2793747).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79962 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G48432 3902292 10827002484327

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SEE H10.