ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
Report
- Report Number
- 1820334-2023-00916
- Event Type
- Injury
- Date Received
- July 17, 2023
- Date of Event
- June 27, 2023
- Report Date
- September 25, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002484181
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CUSTOMER (PERSON): MOBILE: (B)(6). 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. (B)(6) INFORMED COOK ON 27JUN2023 OF AN EVENT WITH A 78-YEAR-OLD PATIENT WITH A TYPE 3 ENDOLEAK. THE COMPLAINT DEVICE WAS ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY RPN: TFFB-28-96-ZT (PRODUCT LOT 3812613). IN (B)(6) 2013, THE FOLLOWING DEVICES WERE IMPLANTED: ZENITH FLEX RPN: TFFB-28-96-ZT WITH CONTRALATERAL/IPSILATERAL ILIAC LEG GRAFTS, ZENITH SPIRAL RPN: ZSLE-16-90-ZT AND ZENITH SPIRAL RPN: ZSLE-13-56-ZT AT ABDOMINAL AORTA. IN 2023, A TYPE 3 ENDOLEAK IS PRESENT AND WOULD NOT ALIGN THE GRAFT FULL BODY STARTING FROM INFRA-RENAL. THE PHYSICIAN PREFERRED TO DESIGN THE CMD (CUSTOM MADE DEVICE) GRAFT AS BIFURCATED WITH LEFT INVERT-LIMB AND DISTAL END AS BOTH COMMON ILIAC ARTERIES. THE PHYSICIAN PERFORMED EVAR UNDER GENERAL ANESTHESIA, SUPINE IN POSITION. SKIN INCISION WAS DONE AT BOTH GROINS, APPROACH TO BOTH FEMORAL ARTERIES. THE GUIDE WAS INSERTED UNDER FLOUROSCOPY. THE PLASTIC SHEATH WAS INSERTED, AND CONTRAST MEDIA WAS INJECTED. THE MAIN BODY (TFFB-28-96-ZT) WAS INSERTED INTO THE LEFT GROIN. THE EXTENSION ILIAC LEGS (ZSLE-13-56-ZT AND ZSLE-16-90-ZT) WERE INSERTED. CONTRAST MEDIA WAS INJECTED, AND NO LEAKAGE WAS SEEN. SOFT TISSUE WAS CLOSED WITH A 3-0 ABSORBABLE, SYNTHETIC SUTURE, AND THE SKIN WAS CLOSED WITH A 3-0 NYLON SUTURE. THE INFRA-RENAL ABDOMINAL AORTIC ANEURYSM DIAMETER: 6.7X 6.4CM, LENGTH: 6.7X 6.4CM, TOTAL HEPARIN DOSE 6,000U (REVERSE 1,000U). THE PATIENT HAD A BLOOD LOSS OF 1000CC. THE REP INDICATED THEY ARE NOT AUTHORIZED TO SHARE PRE-EXISTING CONDITIONS OR CO-MORBIDITIES. IT WAS REPORTED THAT NO VESSEL CALCIFICATION OR TORTUOSITY WAS PRESENT IN THE AREA OF THE ENDOLEAK. THE OFFICIAL REPORT OF THE RADIOLOGIST IN OUR HOSPITAL DIAGNOSED ENDOLEAK TYPE 3. FROM THE PREVIOUS OPERATION, DOCTOR HAVE DONE THE AORTOGRAM BUT DID NOT FIND THE ENDOLEAK FROM THE PROXIMAL SEALING." REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO PHYSICAL EXAMINATION COULD BE CONDUCTED. HOWEVER, MEDICAL IMAGING WAS PROVIDED BY THE CUSTOMER FOR EXPERT REVIEW. AN INFRARENAL AAA WAS PREVIOUSLY REPAIRED USING A ZENITH FLEX (TFFB-28-96) MAIN BODY GRAFT, A CONTRALATERAL ZSLE-16-90 ILIAC LEG ON THE RIGHT, AND AN IPSILATERAL ZSLE-13-56 ILIAC LEG ON THE LEFT. AT 10 YEARS POSTOP, CT IMAGING IS REPORTED TO SHOW A TYPE 3 ENDOLEAK. REVIEW OF THIS STUDY DOES NOT DEFINITIVELY SHOW AN ENDOLEAK. THERE IS A FOCAL AREA OF SUSPICION AT THE ANTERIOR GRAFT IN THE PROXIMAL SAC WHERE A SMALL SPOT OF CONTRAST MAY BE SEEN ADJACENT TO THE TFFB GRAFT, BUT NON-CONTRAST IMAGING WOULD BE NEEDED TO COMPARE TO CONFIRM IF THIS IS ACTIVE CONTRAST VERSUS ARTIFACT. IF THIS IS AN ENDOLEAK, IT WOULD BE A TYPE 3B OF THE TFFB GRAFT; HOWEVER, A MUCH LARGER POOL OF CONTRAST WOULD BE EXPECTED WITH A GRAFT DEFECT HERE. THERE ARE NO JUNCTIONAL LEAKS (TYPE 3A) SEEN AT THE LIMBS AS THERE IS MORE THAN ADEQUATE LEG OVERLAP BILATERALLY. THE PROXIMAL SEAL LENGTH IS LESS THAN ADEQUATE (8 MM) BUT NO PROXIMAL ENDOLEAK IS SEEN. THERE ARE VERY SUBTLE DIFFERENCES IN ATTENUATION IN AREAS OF THE AAA SAC, NOTABLY ALONG THE OUTER RIM, WHICH COULD BE A VERY FAINT TYPE 2 ENDOLEAK FROM A PATENT IMA. AGAIN, NON-CONTRAST IMAGING WOULD BE NEEDED TO COMPARE TO DETERMINE IF THIS IS ACTIVE CONTRAST IN THE SAC OR JUST ARTIFACT VARIATION. THESE AREAS DO NOT COMMUNICATE WITH THE GRAFT ITSELF. THERE IS, HOWEVER, A SIGNIFICANT INCREASE IN THE SIZE OF THE AAA SAC FROM 67 MM (REPORTED ON THE INITIAL OPERATIVE NOTE) TO 97 MM ON THE CURRENT STUDY. PREVIOUS IMAGING TO CONFIRM THE PREOP SIZE IS NOT AVAILABLE. ADDITIONALLY, 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 3812613 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH WAS PERFORMED AND NO OTHER COMPLAINTS WERE FOUND ASSOCIATED WITH THE REPORTED LOT. EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE HISTORY RECORD, COMPLAINT HISTORY, DEVICE FAILURE ANALYSIS, AND MANUFACTURING DOCUMENTS 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. THE DEVICE WAS PACKAGED WITH IFU T_ZAAAF_REV4. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. 4 WARNING 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 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. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION O 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. ¿ THE ZENITH FLEX AAA ENDOVASCULAR GRAFT 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. ¿ 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 FLEX AAA ENDOVASCULAR GRAFT. IF CONTRAST-ENHANCED SPIRAL CTA WITH 3- D RECONSTRUCTION IS NOT AVAILABLE, THE PATIENT SHOULD BE REFERRED TO A FACILITY WITH THESE CAPABILITIES. 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 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, STENT FRACTURE OR BARB 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 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. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. ¿ 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. 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 MIGRATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION ¿ SUGICAL 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 ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR ¿ ABILITY TO TOLERATE GENERAL, REGIONAL OR LOCAL ANESTHESIA ¿ ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 16 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH 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 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 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 OF 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 (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 ¿ 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 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 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. ¿ DUPLEX ULTRASOUND IMAGING MAY PROVIDE INFORMATION ON ANEURYSM DIAMETER CHANGES, 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 COMPARED TO CT. BASED ON THE INFORMATION PROVIDED, EXPERT REVIEW OF MEDICAL IMAGING PROVIDED BY THE FACILITY, AND THE RESULTS OF OUR INVESTIGATION, COOK COULD NOT DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED FAILURE. THE IMAGE REVIEWER STATES, ¿THERE IS A FOCAL AREA OF SUSPICION AT THE ANTERIOR GRAFT IN THE PROXIMAL SAC WHERE A SMALL SPOT OF CONTRAST MAY BE SEEN ADJACENT TO THE TFFB GRAFT, BUT NON-CONTRAST IMAGING WOULD BE NEEDED TO COMPARE TO CONFIRM IF THIS IS ACTIVE CONTRAST VERSUS ARTIFACT.¿ THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.
IT WAS REPORTED THAT A TYPE 3 ENDOLEAK WAS IDENTIFIED IN A (B)(6) PATIENT THAT HAD A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED. THE THEN (B)(6) PATIENT WAS DIAGNOSED WITH AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM (DIAMETER: 6.7X 6.4CM, LENGTH: 6.7X 6.4CM) AND UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) PROCEDURE ON (B)(6) 2013, IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY RPN: TFFB-28-96-ZT, LOT: 3812613. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-56-ZT, LOT: 3984758 (IPSILATERAL ILIAC LEG). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-16-90-ZT, LOT: 3781834 (CONTRALATERAL ILIAC LEG). DURING THE INDEX PROCEDURE, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN THE SUPINE POSITION. SKIN INCISIONS WERE MADE ON BOTH GROINS AND AN APPROACH WAS MADE TO THE FEMORAL ARTERY. THE GUIDE WAS INSERTED UNDER FLUOROSCOPY, THE PLASTIC SHEATH WAS INSERTED, AND CONTRAST MEDIA WAS INJECTED, THE MAIN BODY GRAFT (TFFB-28-96-ZT) WAS INSERTED INTO THE LEFT GROIN, FOLLOWED BY THE EXTENSION ILIAC LEGS (ZSLE-13-56-ZT AND ZSLE-16-90-ZT). CONTRAST MEDIA WAS INJECTED AND REVEALED THAT NO LEAKAGES WERE PRESENT. THE SOFT TISSUE AND SKIN WERE THEN CLOSED WITH SUTURES. THE TOTAL HEPARIN DOSE DURING THE PROCEDURE WAS 6,000U (REVERSE 1,000U). ESTIMATED BLOOD LOSS WAS 1000CC. PERIPHERAL PULSE IN THE DORSALIS PEDIS WAS 2+. IN 2023, THE PATIENT PRESENTED WITH A TYPE 3 ENDOLEAK. THE PHYSICIAN IS PLANNING TO RE-LINE WITH A CUSTOM-MADE DEVICE (CMD) THAT WILL BE DESIGNED AS BIFURCATED WITH A LEFT INVERT-LIMB AND DISTAL END AS BOTH COMMON ILIAC ARTERIES. IT WAS REPORTED THAT NO VESSEL CALCIFICATION OR TORTUOSITY WERE PRESENT AT THE AREA OF THE ENDOLEAK. THE FACILITY NOTED THAT, "IN THIS CASE, THE OFFICIAL REPORT OF THE RADIOLOGIST IN OUR HOSPITAL DIAGNOSED ENDOLEAK TYPE 3. FROM THE PREVIOUS OPERATION, DOCTOR HAVE DONE THE AORTOGRAM BUT DID NOT FIND THE ENDOLEAK FROM THE PROXIMAL SEALING." THIS REPORT CAPTURES A TYPE 3 ENDOLEAK ON THE COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GRAFT (TFFB-28-96-ZT, LOT: 3812613). TWO ADDITIONAL REPORTS THAT CAPTURE TYPE 3 ENDOLEAKS ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS (ZSLE-13-56-ZT AND ZSLE-16-90-ZT) ARE REFERENCED IN REPORTS WITH THE PATIENT IDENTIFIER: 401899_WC.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1628522 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 3812613 | 10827002484181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Unknown | Required Intervention | COOK RPN: ZSLE-13-56-ZT, LOT: 3984758| COOK RPN: ZSLE-16-90-ZT, LOT: 3781834| NYLON 3-0| VICRYL 3-0 |