BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 9405811 · Received December 3, 2019

    Report

    Report Number
    1820334-2019-03005
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 11, 2019
    Report Date
    February 14, 2020
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002484075
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, H6- DEVICE CODE. H6 ¿ METHOD CODE: (4114) DEVICE NOT RETURNED. INVESTIGATION / EVALUATION: A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DESIGN HISTORY FILE ESTABLISHED THAT THE AFFECTED PRODUCT IS SAFE AND EFFECTIVE FOR ITS INTENDED USE. THE DHR FOR THE COMPLAINT DEVICE LOT: (9926411) REVEALED NO RECORDED NON-CONFORMANCES. ADDITIONALLY, THIS DEVICE IS A ONE-DEVICE-LOT AND A DATABASE SEARCH REVEALED NO OTHER EVENTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THERE IS ALSO NO EVIDENCE THAT SUGGESTS THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT INSTRUCTIONS FOR USE (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 (GREATER THAN 60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR GREATER THAN 45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (LESS THAN 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. THE SAFETY AND EFFECTIVENESS OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE Z-TRAK INTRODUCTION SYSTEM HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSMS 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. 5.2 POTENTIAL ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM ENLARGEMENT, ANEURYSM RUPTURE AND DEATH, ENDOLEAK. ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION. 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, GREATER THAN OR EQUAL TO 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." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, ENDOLEAKS ARE LISTED AS A POTENTIAL ADVERSE EVENT IN THE PRODUCT IFU AND ARE A KNOWN INHERENT RISK OF THE DEVICE. THE "PIN HOLE" OBSERVED ON THE GRAFT WAS LOCATED AT A STENT APEX ABOVE THE FLOW DIVIDER. THIS LOCATION INDICATES THAT THE LEAK WAS LIKELY THROUGH THE SUTURE HOLE AT THE STENT APEX. SINCE BLOOD WAS ONLY OBSERVED TO BE LEAKING THROUGH THE ONE SUTURE HOLE, IT IS LIKELY THAT THIS SUTURE HOLE WAS ELONGATED. POSSIBLE CAUSES INCLUDE BALLOON EXPANSION DURING THE IMPLANT PROCEDURE, SUTURE BREAK, MANIPULATION OF THE DEVICE DURING DEPLOYMENT, EXCESSIVE FORCE EXERTED ON THE GRAFT DURING LOADING OR THE SUTURING OF THE STENTS ONTO THE GRAFT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT THE PATIENT DECEASED 1-2 DAYS AFTER THE PROCEDURE DUE TO "OTHER COMPLICATIONS".

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS: ZSLE-16-74-ZT (RIGHT) AND ZSLE-16-90-ZT (LEFT). (B)(4). 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 A TYPE 3B ENDOLEAK WAS OBSERVED THROUGH A PIN HOLE IN A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS WERE SUCCESSFULLY IMPLANTED IN A (B)(6) PATIENT DURING AN EMERGENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO REPAIR A RUPTURED ANEURYSM. THE PROCEDURE WENT WELL BUT THE FINAL ANGIOGRAM SHOWED A "LATE DEVELOPING BLUSH". THE PATIENT WAS OPENED UP TO EXPLORE THE CAUSE OF THE ENDOLEAK AS THEIR BLOOD PRESSURE WAS NOT STABLE AFTER IMPLANTATION OF THE DEVICE. UPON OPENING THE PATIENT UP, A SMALL PIN HOLE AT THE "APEX OF STENT FORM ABOVE FLOW DIVIDER" WAS FOUND IN THE MAIN BODY. THE HOLE WAS SUTURED CLOSED AND A SECOND ANGIOGRAM WAS COMPLETED SUCCESSFULLY WITH NO ENDOLEAK PRESENT. THE PATIENT'S BLOOD PRESSURE STABILIZED AFTER REPAIR OF THE GRAFT. THE SHAPE OF THE NECK ANATOMY WAS "PARALLEL NECK ZONE". A 32 CODA BALLOON WAS USED DURING THE PROCEDURE. THE BALLOONING WAS PERFORMED IN THE PROXIMAL & DISTAL SEAL ZONES AND THE GRAFT OVERLAP SECTIONS. THE PHYSICIAN CONFIRMED THAT THE PATIENT EXPIRED A FEW DAYS LATER OF UNRELATED ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF THE PATIENT'S DEATH BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196945 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 9926411 10827002484075

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SEE H10.