ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2023-00364
- Event Type
- Injury
- Date Received
- April 4, 2023
- Report Date
- April 4, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552415
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. ON 23MAR2023, COOK BECAME AWARE OF AN EVENT INVOLVING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT: 3726317). THE EVENT WAS DISCOVERED DURING THE INVESTIGATION PROCESS FOR A SUPRARENAL STENT SEPARATION WHEN THE IMAGING WAS BEING REVIEWED AND THE REVIEWER IDENTIFIED A TYPE 1B ENDOLEAK WITH THE ZSLE-20-56-ZT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE INITIAL PROCEDURE: ZALB-26-118 (LOT 3850195), ZSLE-20-56-ZT (LOT 3726317), AND ZALL-18-36 (LOT 3413921). ON (B)(6) 2014, THE ANEURYSM SAC WAS MEASURING THE SAME SIZE AS IMPLANT DATE. ON (B)(6) 2016, THE ANEURYSM SAC HAD GROWN 1.4CM. IT WAS REPORTED THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS OR COMORBIDITIES. THE PATIENT WAS COMPLIANT WITH FOLLOW UPS PER THE PROTOCOL DESCRIBED IN THE IFU. THE PATIENT REQUIRES A CUSTOM GRAFT TO REPAIR THE ENDOLEAK CAUSED BY GRAFT SEPARATION. REVIEWS 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, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, MEDICAL IMAGING WAS PROVIDED FOR EXPERT IMAGE REVIEW BY A PHYSICIAN. TYPE IB ENDOLEAKS TREATED WITH BILATERAL ZBIS ENDOGRAFTS WERE NOT ORIGINALLY REPORTED BY THE CUSTOMER BUT OBSERVED ON IMAGING REVIEW. IT WAS NOTED THAT THE TYPE 1B ENDOLEAKS COULD HAVE PRODUCED THE REPORTED AORTIC GROWTH BETWEEN 2014 AND 2016 BUT WERE LIKELY UNRELATED TO THE BARE STENT FRACTURES OR THE STENT SEPARATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT APPROPRIATE INSPECTIONS ARE IN PLACE RELATIVE TO THE REPORTED DEVICE FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 3726317 AND GRAFT SUBASSEMBLIES FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE GRAFT SUBASSEMBLY WAS SEWN BY AN APPROVAL VENDOR, AND UPON INCOMING INSPECTION, FOUND ZERO NONCONFORMANCES. IT SHOULD BE NOTED THAT NO OTHER COMPLAINTS HAVE BEEN ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING. THE DEVICE WAS PACKAGED WITH IFU T_ZAAASZ_REV1. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. 4 WARNINGS AND PRECAUTIONS. 4.1 GENERAL. ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, 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. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP. ¿ 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 INTRA-OPERATIVE 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. ¿ THE ZENITH SPIRAL-Z AAA LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS NOT RECOMMENDED IN PATIENTS EXCEEDING WEIGHT AND/OR SIZE LIMITS WHICH COMPROMISE OR PREVENT THE NECESSARY IMAGING REQUIREMENTS. ¿ SUCCESSFUL PATIENT SELECTION REQUIRES SPECIFIC IMAGING AND ACCURATE MEASUREMENTS; PLEASE SEE SECTION 4.3, PRE-PROCEDURE MEASUREMENT TECHNIQUES, AND IMAGING. 4.3 PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING. ¿ CLINICAL EXPERIENCE INDICATES THAT CONTRAST-ENHANCED SPIRAL COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) WITH 3-D RECONSTRUCTION IS THE STRONGLY RECOMMENDED IMAGING MODALITY TO ACCURATELY ASSESS PATIENT ANATOMY PRIOR TO TREATMENT WITH THE ZENITH SPIRAL-Z AAA ILIAC LEG. IF CONTRAST-ENHANCED SPIRAL CTA WITH 3-D RECONSTRUCTION IS NOT AVAILABLE, THE PATIENT SHOULD BE REFERRED TO A FACILITY WITH THESE CAPABILITIES. 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. SPECIFIC FOLLOW-UP GUIDELINES ARE DESCRIBED IN SECTION 12, IMAGING GUIDELINES AND POSTOPERATIVE 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 RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION. 4.4 DEVICE SELECTION ¿ STRICT ADHERENCE OF THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE (TABLE 10.5.1). 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 SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE INTERNAL ILIAC ARTERIES. 5 ADVERSE EVENTS. 5.2 POTENTIAL ADVERSE EVENTS: ¿ ANEURYSM ENLARGEMENT; ¿ ANEURYSM RUPTURE AND DEATH; ¿ CLAUDICATION (E.G., BUTTOCK, LOWER LIMB); ¿ ENDOLEAK; ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; AND CORROSION; ¿ SURGICAL CONVERSION TO OPEN REPAIR. 7 PATIENT SELECTION AND TREATMENT. 7.1 INDIVIDUALIZATION OF TREATMENT. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ PATIENT¿S AGE AND LIFE EXPECTANCY; ¿ CO-MORBIDITIES (E.G., CARDIAC, PULMONARY, OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY); ¿ PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR; ¿ PATIENT¿S ABILITY TO TOLERATE GENERAL, REGIONAL, OR LOCAL ANESTHESIA; ¿ ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 FRENCH TO 16 FRENCH VASCULAR INTRODUCER SHEATH. 8 PATIENT COUNSELING INFORMATION. ¿ 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 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 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; 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 RISK 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 THAT 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. ¿ 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 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 FOLLOW-UP RELATIVE TO THE NEEDS AND CIRCUMSTANCES OF EACH INDIVIDUAL PATIENT. THE MINIMUM REQUIREMENT FOR PATIENT FOLLOW-UP (DESCRIBED IN THE INSTRUCTIONS FOR USE FOR THE ZENITH AAA MAIN BODY OR RENU THAT WAS USED) SHOULD BE MAINTAINED 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. ¿ 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. EVIDENCE PROVIDED BY THE CUSTOMER, COMPLAINT HISTORY, DHR, DEVICE FAILURE ANALYSIS, MANUFACTURING DOCUMENTS, AND VERIFICATION TESTING, SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, AN EXPERT REVIEW OF MEDICAL IMAGING PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. 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.
IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS IDENTIFIED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING THE INVESTIGATION IMAGE REVIEW FOR A SUPRARENAL STENT SEPARATION FROM THE MAIN BODY GRAFT. THE INDEX PROCEDURE OCCURRED IN (B)(6) 2012, IN WHICH THE FOLLOWING COOK GRAFTS WERE IMPLANTED: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-26-118, LOT 3850195); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT: 3726317), LEFT, CONTRALATERAL; ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZALL-18-36, LOT: 3413921) RIGHT, IPSILATERAL. THE ANEURYSM SAC MEASURED THE SAME SIZE IN OCTOBER 2014 AS IT DID ON THE DATE OF IMPLANT. BY NOVEMBER 2016, THE ANEURYSM SAC HAD GROWN 1.4 CM. TEN YEARS POST-OP, THE SUPRARENAL STENT OF THE MAIN BODY GRAFT WAS FOUND TO BE SEPARATED, AND THE PATIENT REQUIRED A CUSTOM-MADE DEVICE (CMD) TO REPAIR THE ENDOLEAK CAUSED BY THE GRAFT SEPARATION. UPON REVIEW OF THE IMAGING DURING THE GRAFT SEPARATION INVESTIGATION, TYPE 1B ENDOLEAKS WERE FOUND ON BOTH ILIAC LEGS. THE TYPE 1B ENDOLEAKS WERE TREATED WITH ZBIS DEVICES. THE PATIENT WAS REPORTED TO BE COMPLIANT WITH FOLLOW UP PROTOCOL AS DESCRIBED IN THE IFU. THIS REPORT CAPTURES THE TYPE 1B ENDOLEAK IDENTIFIED ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT: 3726317), THAT WAS TREATED WITH THE ZBIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383790 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 3726317 | 10827002552415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | COOK ILIAC LEG GRAFT: ZALL-18-36, LOT: 3413921.| COOK MAIN BODY GRAFT: ZALB-26-118, LOT 3850195. |