ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2021-01705
- Event Type
- Malfunction
- Date Received
- July 7, 2021
- Date of Event
- June 15, 2021
- Report Date
- May 14, 2024
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552415
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION METHODIST HOSPITAL SMITH TOWER INFORMED COOK ON 25JUN2021 OF AN INCIDENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-56-ZT) FROM LOT 9420708. THIS PROCEDURE WAS PART OF THE ZENITH P-BRANCH PIVOTAL STUDY ((B)(6)). AT THE TIME OF ENROLLMENT, PRE-PROCEDURE IMAGING CONDUCTED BY METHODIST HOSPITAL SMITH TOWER NOTED A STABLE PARARENAL AORTIC ANEURYSM. THE PROXIMAL SEALING ZONE SHOWED NO CALCIFICATION OR OCCLUSIVE DISEASE. THERE WAS PARTIAL THROMBUS NOTED. CORE LAB ANALYSIS NOTED AN ANEURYSM DIAMETER OF 57.2 MM. THE PATIENT HAD THE FOLLOWING PRE-EXISTING CONDITIONS: AAA (NOT TREATED), PERIPHERAL VASCULAR DISEASE, HYPERTENSION, COPD, CHRONIC RENAL INSUFFICIENCY, DIVERTICULAR DISEASE, AND A WAS A PAST SMOKER. ON (B)(6) 2019, THE 91-YEAR-OLD FEMALE PATIENT UNDERWENT AN EVAR PROCEDURE UNDER GENERAL ANESTHESIA. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS. THE COMPLETION OF THE ANGIOGRAM DEMONSTRATED THAT THE DEVICES WERE PATENT AND CORE LAB NOTED THAT THE DEVICE WAS PATENT. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 500CC AND NO BLOOD PRODUCTS WERE GIVEN INTRA-OPERATIVELY. ON (B)(6) 2021 (749 DAYS POST-PROCEDURE), OCCLUSION WAS NOTED IN THE LEFT ILIAC LIMB. PATIENT WAS CONFIRMED TO BE TAKING ANTIPLATELET MEDICATION AT THEIR POST-PROCEDURE VISIT, SIX-MONTH FOLLOW-UP VISIT AND THE TWELVE-MONTH VISIT. AT THE PATIENT¿S TWO-YEAR VISIT PATIENT STATED THEY WERE NO LONGER TAKING THE ANTIPLATELET MEDICATION. THE SITE DETERMINED THAT THE OCCLUSION OF THE LEFT ILIAC IS NOT LIKELY DUE TO THE DEVICE BUT DUE TO DISEASE IN THE EXTERNAL ILIAC ARTERY DISTAL TO THE LIMB. THERE WAS NO ADDITIONAL TREATMENT COMPLETED FOR THIS INCIDENT. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE CONDUCTED. NO PROCEDURAL IMAGING COULD BE PROVIDED BY THE FACILITY. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 9420708 AND SUBASSEMBLY LOTS SA8541151 AND SA8365247 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH LOT 9420708. 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, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_ZAAASZ_REV3 ¿ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 4.1 GENERAL ¿ PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. 4.2 PATIENT SELECTION, TREATMENT, AND FOLLOW-UP ¿ ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SIRE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. ¿ ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE VASCULATURE. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS, OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. ¿ PRE-EXISTING REGIONS OF STENOSIS/NARROWING (LESS THAN APPROXIMATELY 20 MM ID IN THE AORTA OR 7 TO 8 MM ID IN THE ILIACS) HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ADDITIONALLY, THE COMPLETION ANGIOGRAM (WITH STIFF WIRE GUIDES REMOVED) SHOULD BE REVIEWED CAREFULLY TO DETERMINE IF FURTHER TREATMENT IN THESE REGIONS IS NECESSARY (E.G., ADJUNCTIVE BALLOONING OR STENTING). FAILURE TO REMOVE THE STIFF WIRE GUIDE PRIOR TO THE ANGIOGRAM COULD MASK ANY LIMB KINKING OR NARROWING THAT MIGHT OCCUR WHEN THE WIRE GUIDE IS REMOVED. ¿ FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE LEG GRAFT. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5 MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT (E.G., GRAFT LIMB OCCLUSION). REINTERVENTION (E.G., NONCOMPLIANT BALLOONING OR STENTING IN THESE REGIONS) SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. ¿ THE ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS NOT RECOMMENDED IN PATIENTS WHO CANNOT TOLERATE CONTRAST AGENTS NECESSARY FOR INTRAOPERATIVE AND POSTOPERATIVE FOLLOW-UP IMAGING. ALL PATIENTS SHOULD BE MONITORED CLOSELY AND CHECKED PERIODICALLY FOR A CHANGE IN THE CONDITION OF THEIR DISEASE AND THE INTEGRITY OF THE ENDOPROSTHESIS. ¿ INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA. LENGTHS ¿ 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 FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED 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 BETWEEN COMPONENTS OR STENT FRACTURE) 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 REDIOPGREAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. 4.5 IMPLANT PROCEDURE ¿ UNLESS MEDICALLY INDICATED, DO NOT DEPLOY THE ZENITH SPIRAL-Z ENDOVASCULAR AAA ILIAC LEG IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z ENDOVASCULAR AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT/ SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATION; EROSION; PUNCTURE; PERGRAFT FLOW; AND CORROSION. ¿ GRAFT OR NATIVE VESSEL OCCLUSION. 7.1 INDIVIDUALIZATION OF TREATMENT ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED ¿ PATIENT¿S AGE AND LIFE EXPECTANCY. ¿ CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY). ¿ FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT. 8 PATIENT COUNSELING INFORMATION IN ADDITION TO THE RISKS AND BENEFITS OF AN ENDOVASCULAR REPAIR, THE PHYSICIAN SHOULD ASSESS THE PATIENT¿S COMMITMENT AND COMPLIANCE TO POSTOPERATIVE FOLLOW-UP AS NECESSARY TO ENSURE CONTINUING SAFE AND EFFECTIVE RESULTS. LISTED BELOW ARE ADDITIONAL TOPICS TO DISCUSS WITH THE PATIENT AS TO EXPECTATIONS AFTER AN ENDOVASCULAR REPAIR: ¿ 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 FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED 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 IS REQUIRED AND SHOULD BE CONSIDERED A LIFE-LONG COMMITMENT TO THE PATIENT¿S HEALTH AND WELL-BEING. ¿ PHYSICIANS MUST ADVISE ALL PATIENTS 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 COMPLICATIONS. DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE, AND DEATH. PRE-IMPLANT DETERMINANTS VERIFY FROM PRE-IMPLANT PLANNING THAT THE CORRECT DEVICE HAS BEEN SELECTED. DETERMINANTS INCLUDE: 1. FEMORAL ARTERY SELECTION FOR INTRODUCTION OF THE DELIVERY SYSTEM (I.E., DEFINE RESPECTIVE CONTRALATERAL AND IPSILATERAL ILIAC ARTERIES). 2. ANGULATION OF AORTIC NECK, ANEURYSM, AND ILIAC ARTERIES. 3. DIAMETERS OF INFRARENAL AORTIC NECK AND DISTAL ILIAC ARTERIES. 4. LENGTH FROM THE AORTIC BIFURCATION OF A PREVIOUSLY PLACED MAIN BODY OR RENU FROM THE ZENITH AAA ENDOVASCULAR GRAFT FAMILY OF PRODUCTS TO THE INTERNAL ILIAC ARTERIES/ATTACHMENT SITE(S). 5. ANEURYSM(S) EXTENDING INTO THE ILIAC ARTERIES MAY REQUIRE SPECIAL CONSIDERATION IN SELECTING A SUITABLE GRAFT/ARTERY INTERFACE SITE. 6. DEGREE OF VASCULAR CALCIFICATION. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE HISTORY RECORD, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING, SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE FAILURE WAS LIKELY DUE TO AN ADVERSE EVENT RELATED TO THE PATIENT CONDITION. THE PATIENT DID HAVE PRE-EXISTING CONDITIONS OF PERIPHERAL VASCULAR DISEASE AND CHRONIC RENAL INSUFFICIENCY. PER THE IFU SECTION 7 PATIENT SELECTION AND TREATMENT, THE RISKS AND BENEFITS SHOULD BE CAREFULLY CONSIDERED FOR EACH PATIENT BEFORE THE USE OF THE ZENITH ALPHA SPIRAL-Z ENDOVASCULAR LEG. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: "CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY), FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT, AND THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT." THE SITE NOTED THAT PREEXISTING THROMBUS WAS PRESENT BEFORE THE PLACEMENT OF THE DEVICE. IN ADDITION TO THIS, THE SITE ALSO STATED THAT THE OCCLUSION OF THE LEFT ILIAC IS NOT LIKELY DUE TO THE DEVICE BUT DUE TO DISEASE IN THE EXTERNAL ILIAC ARTERY DISTAL TO THE LIMB. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
CORRECTION: H6 - ANNEX A. ADDITIONAL INFORMATION: B5. 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.
THE INVESTIGATION CONCLUSION WAS NOT IMPACTED BY THE REPORT OF ADDITIONAL INFORMATION. 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.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED ON 20JUL2021 AND 03AUG2021. IT WAS REPORTED THAT THE LEFT ILIAC LIMB IS COMPLETELY OCCLUDED. THE USER ATTRIBUTES THIS OCCLUSION TO LIKELY BE A RESULT OF DISEASE IN THE EXTERNAL ILIAC ARTERY DISTAL TO THE LIMB. PRIOR TO THE INITIAL EVAR PROCEDURE, THE PATIENT WAS TAKING 81MG OF ASPIRIN ONCE A DAY. THE PATIENT WAS REPORTED TO BE TAKING ANTIPLATELET MEDICATIONS AT THEIR POST-PROCEDURE VISIT, 6-MONTH VISIT, AND 12-MONTH VISIT. AT THEIR 2-YEAR VISIT, THE PATIENT STATED THEY WERE NOT CURRENTLY TAKING ANTIPLATELET MEDICATIONS. THE PATIENT'S DAUGHTER REPORTED THAT ONE OF THE PATIENT'S PHYSICIANS DISCONTINUED THE ASPIRIN REGIMEN FOR UNKNOWN REASONS.
ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024. THERE WAS NO TREATMENT FOR THE LEFT LIMB OCCLUSION THAT OCCURRED 749 DAYS POST PROCEDURE. THE PATIENT DIED 999 DAYS AFTER THE PROCEDURE DUE TO AN UNKNOWN CAUSE.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED A FEMALE STUDY PATIENT REQUIRED IMPLANTATION OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG ALONG WITH A MAIN BODY GRAFT, A RIGHT ILIAC LEG GRAFT, AND A BRANCHED ENDOVASCULAR GRAFT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE PERFORMED UNDER GENERAL ANESTHESIA. A COMPETITOR SMA COVERED STENT ALONG WITH ONE LEFT AND TWO RIGHT RENAL COMPETITOR COVERED STENTS WERE ALSO IMPLANTED. ADDITIONALLY, A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS. AT THE TIME OF ENROLLMENT IN THE STUDY, PRE-PROCEDURAL IMAGING REVEALED A STABLE PARARENAL AORTIC ANEURYSM WITH A DIAMETER OF 57.2 MM. IMAGING CONDUCTED BY THE STUDY SITE CONCLUDED THAT THE PROXIMAL SEALING ZONE SHOWED NO CALCIFICATION OR OCCLUSIVE DISEASE, THOUGH THERE WAS PARTIAL THROMBUS. CORE LAB ANALYSIS DID NOT DETECT ANY CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS IN THE PROXIMAL SEALING ZONE. FOLLOWING THE EVAR PROCEDURE, COMPLETION ANGIOGRAM REVEALED PATENT DEVICES. CORE LAB ALSO NOTED THAT THE DEVICES WERE PATENT. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 500 CC, AND NO BLOOD PRODUCTS WERE GIVEN INTRA-OPERATIVELY. ON (B)(6) 2021 (749 DAYS POST-PROCEDURE), THE LEFT ILIAC LIMB WAS NOTED TO BE OCCLUDED. NO TREATMENT HAS BEEN PERFORMED. THE SITE DOES NOT SUSPECT THAT THE OCCLUSION WAS RELATED TO THE DEVICE OR STUDY PROCEDURE. THE PATIENT REMAINS IN THE STUDY AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1028636 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | G55241 | 9420708 | 10827002552415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Female | ATRIUM RENAL COVERED STENT (L) 7MMX22MM| ATRIUM RENAL COVERED STENT (R) 6MMX22MM| ATRIUM RENAL COVERED STENT (R) 7MMX22MM| ATRIUM SMA COVERED STENT 7MMX38MM| COOK PBRANCH-36-22-B-CL| COOK UNIBODY-24-81-CI| COOK ZSLE-20-39-ZT |