ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2021-02358
- Event Type
- Death
- Date Received
- October 20, 2021
- Report Date
- April 7, 2025
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002484334
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. CORRECTION: D10 . ADDITIONAL INFORMATION: B5, B7, D4 (LOT NUMBER), H6 - ANNEX G. INVESTIGATION-EVALUATION: ON 14OCT2021 COOK BECAME AWARE OF AN INCIDENT BY A PHYSICIAN AT (B)(6) , WHERE STENT SEPARATION FROM THE GRAFT WAS NOTED WITH THE COMPLAINT DEVICE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY RPN: TFFB-36-113-ZT LOT: 6232409. ON (B)(6) 2016 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR). THE FOLLOWING COOK GRAFTS WERE PLACED DURING THE PROCEDURE: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-13-113), ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20 -90), IPSILATERAL, LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74), CONTRALATERAL, RIGHT ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN:ZBIS-12- 45-41), CONTRALATERAL, RIGHT. DURING THE PROCEDURE, THERE WAS A MINOR ACCESS ISSUE DUE TO A PRE-EXISTING OCCLUSION OF THE SUPERIOR FEMORAL ARTERY (SFA) ON THE LEFT SIDE. IT WAS REPORTED THAT THE BARE RENAL SUPRA RENAL STENT OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY PLACED IN THE EVAR ON (B)(6) 2016 HAD SEPARATED FROM ITS GRAFT FABRIC. THE STENT WAS REPORTED TO BE "IN PIECES." ADDITIONALLY, A RUPTURE HAD OCCURRED (DATE UNKNOWN). THE LOCATION OF THE RUPTURE WAS NOT SPECIFIED. AN OPEN CONVERSION WAS PLANNED. THE PATIENT LATER DIED FROM AN UNSPECIFIED COMORBIDITY ON AN UNKNOWN DATE BEFORE OPEN CONVERSION COULD BE COMPLETED. COOK WAS FIRST MADE AWARE THAT THE PATIENT ASSOCIATED WITH THIS EVENT HAD DIED ON 08MAR2022. A REVIEW OF THE DOCUMENTATION INCLUDING COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION, BUT DID PROVIDE MEDICAL IMAGING. THE IMAGING REVIEW CONFIRMED A FRACTURE OF THE SUPRARENAL STENT. THE CAUSE OF THIS CANNOT BE DETERMINED, BUT THERE IS SIGNIFICANT TORTUOSITY OF THE PROXIMAL NECK WITH A 77-DEGREE ANGULATION OF THE SUPRARENAL AORTA RELATIVE TO THE NECK ON THE PREOP COMPUTED TOMOGRAPHY (CT) SCAN. THE PROXIMAL SUPRARENAL STENT LANDS IN THIS ANGULATION AND CONTINUED PRESSURE ON THE STENT HERE OVER TIME MAY HAVE CONTRIBUTED TO THE FRACTURE. THE PROXIMAL NECK TORTUOSITY ON PREOPERATIVE IMAGING (WITH A 77-DEGREE SUPRARENAL ANGULATION AND 73-DEGREE INFRARENAL ANGULATION) IS OUTSIDE THE IFU FOR THIS DEVICE. THERE IS ALSO LOSS OF PROXIMAL SEAL WITH ANEURYSMAL DILATION OF THE PROXIMAL NECK AND DISTAL MIGRATION OF THE FLEX GRAFT INTO THE PROXIMAL AAA SAC AT 67 WEEKS. NO TYPE 1A ENDOLEAK IS EVIDENT, HOWEVER. IT CANNOT BE DETERMINED IF GRAFT MIGRATION LED TO THE LOSS OF SEAL AND NECK DILATION OR VICE VERSA DUE TO DISEASE PROGRESSION IN THE NECK. ON PREOP IMAGING, HOWEVER, THE PROXIMAL NECK IS ONLY 10 MM IN LENGTH AND INADEQUATE FOR ENDOVASCULAR REPAIR, SO THE DEVICE WAS USED OUTSIDE OF IFU INDICATION. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 6232409 AND GRAFT KIT LOT SA5776207 HAD ONE NONCONFORMANCE EACH; HOWEVER, THE DEVICES WERE RE-WORKED AND RE-INSPECTED PRIOR TO FURTHER PROCESSING. GRAFT SUBASSEMBLY LOT SA6080395 HAD NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE GRAFT SUBASSEMBLY LOT (1497683.3) WAS SEWN BY APPROVED VENDOR SEI MEDICAL S.A. UPON INCOMING INSPECTION ZERO NONCONFORMANCE¿S WERE DETECTED. A COMPLAINT SEARCH REVEALED NO OTHER COMPLAINTS ASSOCIATED TO THE LOT NUMBER 6232409. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE PACKAGED WITH THE DEVICE (T_ZAAAF_REV5) STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: 4 WARNINGS AND PRECAUTIONS 4.1 GENERAL ¿ READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS AND PRECAUTIONS MAY LEAD TO SERIOUS CONSEQUENCES OR INJURY TO THE PATIENT. ¿ 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. ¿ PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. ¿ 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 (<15 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM 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. 4.3 PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING LENGTHS ¿ THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDING (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 POSTOPERATIVVE FOLLOW-UP. ¿ AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED, INCLUDING: 1) ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (SEPARATION) AND 2) CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. 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 IN FOLDING OR COMPRESSION. 4.5 IMPLANT PROCEDURE ¿ INADVERTENT PARTIAL DEPLOYMENT OR MIGRATION OF THE ENDOPROSTHESIS MAY REQUIRE SURGICAL REMOVAL. ¿ 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. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. ¿ 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. ¿ FLUOROSCOPY SHOULD BE USED DURING INTRODUCTION AND DEPLOYMENT TO CONFIRM PROPER OPERATION OF THE DELIVERY SYSTEM COMPONENTS, PROPER PLACEMENT OF THE GRAFT, AND DESIRED PROCEDURAL OUTCOME. ¿ AVOID DAMAGING THE GRAFT OR DISTURBING GRAFT POSITIONING AFTER PLACEMENT IN THE EVENT RE-INSTRUMENTATION (SECONDARY INTERVENTION) OF THE GRAFT IS NECESSARY. 5 ADVERSE EVENTS 5.2 POTENTIAL ADVERSE EVENTS ¿ ANEURYSM ENLARGEMENT ¿ ANEURYSM RUPTURE AND DEATH ¿ CLAUDICATION (E.G., BUTTOCK, LOWER LIMB) ¿ ENDOLEAK 8 PATIENT COUNSELING INFORMATION ¿ THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDING (E.G., ENDOLEAKS, ENLARGING ANEURYSMS 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. ¿ PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS A CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAAS. AT A MINIMUM, ANNUAL IMAGING AND ADHERENCE TO ROUTINE POSTOPERATIVE FOLLOW-UP REQUIREMENTS ARE REQUIRED AND SHOULD BE CONSIDERED A LIFELONG COMMITMENT TO THE PATIENT¿S HEALTH AND WELL-BEING. ¿ PHYSICIANS MUST ADVISE EACH PATIENT THAT IT IS IMPORTANT TO SEEK PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE SIGNS OF LIMB OCCLUSION, ANEURYSM ENLARGEMENT OR RUPTURE. SIGNS OF GRAFT LIMB OCCLUSION INCLUDE PAIN IN THE HIP(S) OR LEG(S) DURING WALKING OR AT REST OR DISCOLORATION OR COOLNESS OF THE LEG. ANEURYSM RUPTURE MAY BE ASYMPTOMATIC, BUT USUALLY PRESENTS AS: PAIN; NUMBNESS; WEAKNESS IN THE LEGS; ANY BACK, CHEST, ABDOMINAL OR GROIN PAIN; DIZZINESS; FAINTING; RAPID HEARTBEAT OR SUDDEN WEAKNESS. PHYSICIANS SHOULD REFER PATIENTS TO THE PATIENT GUIDE REGARDING RISKS OCCURRING DURING OR AFTER IMPLANTATION OF THE DEVICE. PROCEDURE-RELATED RISKS INCLUDE CARDIAC, PULMONARY, NEUROLOGIC, BOWEL AND BLEEDING COMPLICATION. DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE AND DEATH (SEE SECTION 5.1, OBSERVED ADVERSE EVENTS AND SECTION 5.2, POTENTIAL ADVERSE EVENTS). THE PHYSICIAN SHOULD COMPLETE THE PATIENT I.D. CARD AND GIVE IT TO THE PATIENT SO HE/SHE CAN CARRY IT WITH HIM/HER AT ALL TIMES. THE PATIENT SHOULD REFER TO THE CARD ANYTIME HE/SHE VISITS ADDITIONAL HEALTH PRACTITIONERS, PARTICULARLY FOR ANY ADDITIONAL DIAGNOSTIC PROCEDURES (E.G., MRI). 12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP. 12.1 GENERAL ¿ THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDING (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. PATIENTS SHOULD BE COUNSELED ON THE IMPORTANCE OF ADHERING TO THE FOLLOW-UP SCHEDULE, BOTH DURING THE FIRST YEAR AND AT YEARLY INTERVALS THEREAFTER. PATIENTS SHOULD BE TOLD THAT REGULAR AND CONSISTENT FOLLOW-UP IS A CRITICAL PART OF ENSURING THE ONGOING SAFETY AND EFFECTIVENESS OF ENDOVASCULAR TREATMENT OF AAAS. ¿ PHYSICIANS SHOULD EVALUATE PATIENTS ON AN INDIVIDUAL BASIS AND PRESCRIBE THEIR FOLLOW-UP RELATIVE TO THE NEEDS AND CIRCUMSTANCES OF EACH INDIVIDUAL PATIENT. THE RECOMMENDED IMAGING SCHEDULE IS PRESENTED IN TABLE 12.1.1. THIS SCHEDULE WAS USED IN THE PIVOTAL TRIAL AND IS RECOMMENDED EVEN IN THE ABSENCE OF CLINICAL SYMPTOMS (E.G., PAIN, NUMBNESS, WEAKNESS). PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE STENT GRAFT) SHOULD RECEIVE FOLLOW-UP AT MORE FREQUENT INTERVALS. ¿ THE COMBINATION OF CONTRAST AND NON-CONTRAST CT IMAGING PROVIDES INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, PROGRESSIVE DISEASE, FIXATION LENGTH AND OTHER MORPHOLOGICAL CHANGES. ¿ THE ABDOMINAL RADIOGRAPHS PROVIDE INFORMATION ON DEVICE INTEGRITY (SEPARATION BETWEEN COMPONENTS, STENT FRACTURE AND BARB SEPARATION). ¿ DUPLEX ULTRASOUND IMAGING MAY PROVIDE INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE. IN THIS CIRCUMSTANCE, A NON-CONTRAST CT SHOULD BE PERFORMED TO USE IN CONJUNCTION WITH THE ULTRASOUND. ULTRASOUND MAY BE A LESS RELIABLE AND SENSITIVE DIAGNOSTIC METHOD COMPARED TO CT. AFTER REVIEW OF THE IFU, COOK HAS CONCLUDED THE DEVICE LABELING CONTAINS APPROPRIATE WARNINGS, PRECAUTIONS AND INSTRUCTIONS TO THE USER RELATED TO THE REPORTED FAILURE. BASED ON THE PROVIDED EVIDENCE AND THE COMPLETED INVESTIGATION, COOK HAS DETERMINED THAT A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY AND PROVIDED IMAGING. POSSIBLE CAUSES INCLUDE DEVICE BEING USED OUTSIDE OF IFU FOR SUPRA/INFRARENAL ANGULATION AND A PROXIMAL NECK ONLY 10 MM IN LENGTH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK 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.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5, D10 (CONCOMITANT PRODUCTS). CORRECTION: B2, H6 (ANNEX E). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION-EVALUATION: THE INVESTIGATION EVALUATION RESULTS DID NOT CHANGE FROM THE PREVIOUS REPORT BASED ON THE ADDITIONAL INFORMATION PROVIDED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IN ADDITIONAL INFORMATION RECEIVED ON 02JUN2022, IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THERE WAS A MINOR ACCESS ISSUE DUE TO A PRE-EXISTING OCCLUSION OF THE SUPERIOR FEMORAL ARTERY ON THE LEFT SIDE. THE PATIENT HAD HISTORY OF AN ASYMPTOMATIC CAROTID ARTERY OCCLUSION AND HAD PREVIOUSLY UNDERGONE AORTIC VALVE REPLACEMENT. THE PATIENT WAS COMPLIANT WITH FOLLOW UP PROTOCOL. AN OPEN CONVERSION PROCEDURE WAS PLANNED TO TREAT THE SEPARATION OF THE SUPRARENAL STENT . HOWEVER, THE PATIENT DIED BEFORE THE INTERVENTION COULD BE COMPLETED DUE TO OTHER CAUSES.
ADDITIONAL INFORMATION RECEIVED ON 08MAR2022 STATED THAT THE BARE SUPRA RENAL FIXATION CAME LOSE FROM THE FABRIC OF THE GRAFT. IT WAS ALSO REPORTED THAT A RUPTURE OCCURRED HOWEVER THE LOCATION OF THE RUPTURE WAS NOT SPECIFIED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM "COMORBIDITY." COOK WAS FIRST MADE AWARE THAT THE PATIENT ASSOCIATED WITH THIS EVENT HAD PASSED AWAY ON (B)(6) 2022. COOK HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE PATIENT'S CAUSE OF DEATH HOWEVER NO RESPONSE HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
ADDITIONAL INFORMATION WAS PROVIDED ON 26FEB2025. THE PATIENT REPORTED AS THE "SECOND CASE" IN THE JOURNAL ARTICLE "ENDOVASCULAR GRAFT SUPRARENAL BARE METAL STENT SEPARATION AFTER ENDOVASCULAR ANEURYSM REPAIR: CASE REPORTS AND LITERATURE REVIEW" PUBLISHED IN THE EJVES VASCULAR FORUM JOURNAL WAS LINKED TO THE PATIENT THAT IS THE SUBJECT OF THIS REPORT. "THE SECOND CASE INVOLVED A 74-YEAR-OLD MAN WITH A HISTORY OF ARTERIAL CALCIFICATIONS AND MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. A 62 MM INFRARENAL AAA (AORTIC NECK LENGTH OF 15 MM AND NECK DIAMETER OF 31 MM) WAS DISCOVERED INCIDENTALLY ON FOLLOW UP CTA OF THE HEART, FOR WHICH EVAR WAS PERFORMED IN (B)(6) 2016 (ZENITH FLEX AAA ENDOVASCULAR GRAFT, COOK MEDICAL, BLOOMINGTON, IN, USA; 22FR 36 X 113 MM, LEFT LEG 16 X 74 MM ELONGATED WITH A 20 X 90 MM LEG, COMBINED WITH A ZENITH RIGHT SIDED ILIAC BRANCHED DEVICE, COOK MEDICAL, BLOOMINGTON, IN, USA; 45 X 41 MM). THIS PROCEDURE WAS PERFORMED OUTSIDE THE IFU AS THE AORTIC NECK ANGULATION RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA WAS MEASURED AT 61 DEGREES WHEREAS AN ANGLE SMALLER THAN 45 DEGREES IS RECOMMENDED. FOLLOW UP CTA AND DUPLEX ULTRASOUND IMAGING SHOWED A GRADUAL SHRINKAGE OF THE AAA DIAMETER DOWN TO A MINIMUM OF 54 MM AND NO SIGNS OF AN ENDOLEAK DURING THE FIRST FOUR YEARS OF FOLLOW UP. FIVE YEARS AND EIGHT MONTHS POST IMPLANTATION, THE PATIENT DEVELOPED PROGRESSIVE DYSPNEA ON EXERTION. DURING CARDIAC EXAMINATION, AN ENLARGEMENT OF THE AAA SAC TO 65 MM IN DIAMETER WAS FOUND, ACCOMPANIED BY SUPRARENAL BARE METAL STENT SEPARATION AND DISTAL GRAFT MIGRATION OF THE ENDOVASCULAR GRAFT LEADING TO A TYPE IA ENDOLEAK (FIG. 3). A 360 DEGREES ANGLE 3D RECONSTRUCTION OF THIS MECHANICAL FAILURE IS PROVIDED IN SUPPLEMENTARY VIDEO S1. BECAUSE OF AORTIC ANGULATION AND TECHNICAL DIFFICULTIES RAISED BY THE STENT GRAFT DEFECT IN COMBINATION WITH A FAST-GROWING ANEURYSM, THE PATIENT WAS SCHEDULED FOR OPEN REPAIR. UNFORTUNATELY, SURGERY WAS POSTPONED DUE TO THE PATIENT¿S COMORBIDITIES, INCLUDING POSSIBLE NON-SMALL CELL LUNG CANCER (CT1AN0M0) AND AN INTRATHORACIC STOMACH. THE PATIENT DIED AS A RESULT OF MULTIORGAN FAILURE INDUCED BY ABDOMINAL SEPSIS RESULTING FROM INTESTINAL ISCHEMIA BEFORE SURGERY OF HIS ANEURYSM COULD TAKE PLACE." VAN DER KROGT, J. M. A., VAN ERP, A. C., SMORENBURG, S. P. M., WILLEMS, M. C. M., & NEDERHOED, J. H. (2023). ENDOVASCULAR GRAFT SUPRARENAL BARE METAL STENT SEPARATION AFTER ENDOVASCULAR ANEURYSM REPAIR: CASE REPORTS AND LITERATURE REVIEW. EJVES VASCULAR FORUM, 60, 28¿32. HTTPS://DOI.ORG/10.1016/J.EJVSVF.2023.06.00.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IMPLANT DATE: 2016 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED AN UNKNOWN PATIENT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN 2016. SOME TIME AFTER THE PROCEDURE, THE BARE STENT BROKE OFF AND "IS IN PIECES". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565746 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 6232409 | 10827002484334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Death| S | COOK ILIAC BIFURCATION GRAFT, RPN: ZBIS-12- 45-41| COOK ILIAC LEG GRAFT, RPN: ZSLE-16-74| COOK ILIAC LEG GRAFT, RPN: ZSLE-20 -90| LUNDERQUIST WIRE GUIDE| PIGTAIL CATHETER |