ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2023-00018
- Event Type
- Injury
- Date Received
- February 22, 2023
- Report Date
- April 6, 2023
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO IMAGING WAS OBTAINED TO ASSIST WITH THE INVESTIGATION. WCA'S MEDICAL DIRECTOR REVIEW THE JOURNAL ARTICLE AND STATED: "THOSE ADVERSE EVENTS WERE ONLY MENTIONED IN PASSING, WITH NO DETAILS OR POSSIBLE CAUSES OF FAILURE. ALL WERE TREATED AND RECOVERED WITH NO RESIDUAL PROBLEMS. I CAN¿T COMMENT ON POSSIBLE CAUSES, AS WE HAVE NO DETAILS ON THOSE INDIVIDUAL CASES/PATIENTS. CAUSES COULD RANGE FROM PROCEDURAL MANIPULATION, INADEQUATE ANTI-COAGULATION, LACK OF ANTI-PLATELET MEDICATION, ETC. IT SEEMS, AS FAR AS I CAN GATHER, THAT ALL OF THE EVENTS WERE EITHER INTRAOPERATIVE OR IN THE FIRST DAY OR SO POST-OP. THE ONLY ONE NOT CLEAR IS THE TIMESCALE OF THE PATIENT WHO DEVELOPED DISTAL AORTIC OCCLUSION WITH BILATERAL ACUTE LIMB ISCHAEMIA. HOWEVER, READING BETWEEN THE LINES, I WOULD GUESS THAT THIS ALSO OCCURRED IN THE FIRST COUPLE OF DAYS POST-OP. THESE ARE ALL DOCUMENTED ADVERSE EVENTS, AND IN THESE CASES, ALL WERE TREATED SUCCESSFULLY. SORRY I CAN¿T SHED ANY MORE LIGHT ON THEM, AS THEY WERE ONLY MENTIONED ONCE BRIEFLY IN THE PAPER, WITH NO OTHER INFORMATION ON WHICH TO BASE ANY POSSIBLE CAUSES." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED. AS THE LOT NUMBER WAS NOT PROVIDED, THE REVIEW OF THE WORK ORDER AND SPECIFIC MANUFACTURING RECORDS FOR THE DEVICE USED WAS NOT ABLE TO BE CONDUCTED. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE STATES THE FOLLOWING: 4. WARNINGS AND PRECAUTIONS 4.3 IMPLANT PROCEDURE ¿ SYSTEMIC ANTICOAGULATION SHOULD BE USED DURING THE IMPLANTATION PROCEDURE BASED ON HOSPITAL AND PHYSICIAN PREFERRED PROTOCOL. IF HEPARIN IS CONTRAINDICATED, AN ALTERNATIVE ANTICOAGULANT SHOULD BE CONSIDERED. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FENESTRATED 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. IT IS RECOMMENDED THAT ALL VESSELS ACCOMMODATED BY A SMALL FENESTRATION BE STENTED IN ORDER TO SECURE POSITIVE ALIGNMENT OF THE GRAFT FENESTRATION WITH THE VESSEL ORIGIN. 5. ADVERSE EVENTS: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM. ¿ OCCLUSION OF DEVICE OR NATIVE VESSEL. ¿ RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY STENOSIS OR OCCLUSION, CONTRAST TOXICITY, INFARCT, INSUFFICIENCY, FAILURE). THIS IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION AND THE COMPLETED INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE EVENT WAS NOT ABLE TO BE DETERMINED. POSSIBLE ROOT CAUSES ARE: - TWISTING OF IMPLANT WITHIN THE DELIVERY SYSTEM. - KINKING/ COLLAPSE/ EXCESSIVE PROLAPSE OF IMPLANT/ FOLDING OF IMPLANT MATERIAL BETWEEN STENTS. - COLLAPSE OF IMPLANT DUE TO STENT FRACTURE/DETACHMENT. - ROUGH SURFACE PRONE TO THROMBUS FORMATION. - INADEQUATE MEDICATION OF PATIENT WITH ANTI-COAGULANTS. - INADEQUATE SPACING BETWEEN STENTS. - PATIENT'S FACTORS. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. THE MANDATORY REQUIREMENT TO ALWAYS CHECK COMPLAINTS HISTORY DURING A COMPLAINT INVESTIGATION WILL ENSURE TRENDS ARE CONSTANTLY MONITORED. AFTER CONSIDERING THIS EVENT THE BENEFITS OF USING THIS DEVICE STILL OUTWEIGH THE KNOWN RISKS.
SABINA M. SORONDO 2022, "LARGE FENESTRATIONS VERSUS SCALLOPS FOR THE SUPERIOR MESENTERIC ARTERY DURING FENESTRATED ENDOVASCULAR ANEURYSM REPAIR: DOES IT MATTER?" THE STUDY SOUGHT TO COMPARE MIDTERM CLINICAL OUTCOMES AND SAC REGRESSION OF PATIENTS TREATED WITH THE COOK ZFEN, FROM SEPTEMBER 2021 TO JULY 2021, BETWEEN THE 2 DIFFERENT SMA CONFIGURATIONS: SMA SCALLOP OR LARGE FENESTRATION. 137 ZFEN PATIENTS HAD EITHER A SCALLOP OR A LARGE FENESTRATION FOR THE SMA AS THE PROXIMAL-MOST CONFIGURATION. OF THESE, 72 PATIENTS (52.6%) UNDERWENT REPAIR UTILIZING A SCALLOP CONFIGURATION, AND 65 PATIENTS (47.4%) UNDERWENT A LARGE FENESTRATION. THE PRIMARY OUTCOME OF INTEREST WAS SAC REGRESSION AT 1 YEAR. SECONDARY OUTCOMES INCLUDED PROXIMAL NECK REINTERVENTION RATES, 30-DAY MORTALITY, AND AN OVERALL 3-YEAR SURVIVAL. ALL FIRST POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS (1-30 DAYS) WERE ANALYZED INDEPENDENTLY FOR PROXIMAL SEAL ZONE LENGTHS. PROXIMAL SEAL ZONE LENGTH WAS DEFINED AS THE DISTANCE FROM THE PROXIMAL GRAFT FABRIC TO THE START OF THE ANEURYSM IN LARGE FENESTRATIONS AND THE DISTANCE FROM THE BASE OF THE SCALLOP TO THE ANEURYSM FOR SCALLOP CONFIGURATIONS. ANEURYSM CHARACTERISTICS AND MORPHOLOGY RELATED TO THE NECK DIFFERED SIGNIFICANTLY BETWEEN THE 2 CONFIGURATIONS. WHILE MAXIMUM ANEURYSM-SIZE DID NOT DIFFER SIGNIFICANTLY BETWEEN THE SCALLOP AND LARGE FENESTRATION GROUPS (61.6 ± 13.2 MM VS. 63.7 ± 13.4 MM, P = 0.33), THE SCALLOP GROUP HAD A SIGNIFICANTLY SMALLER INFRARENAL NECK DIAMETER (25.0 ± 5.32 VS. 26.9 ± 6.26, P = 0.044), LARGER SUPRARENAL NECK ANGULATION (24.3 ± 19.0 VS. 16.7 ± 11.1, P = 0.003), AND SMALLER DEVICE DIAMETER (29.5 ± 3.24 VS. 31.5 ± 3.23, P = 0.0002) AS COMPARED TO THE LARGE FENESTRATION GROUP. WITH REGARDS TO PERIOPERATIVE OUTCOMES, OPERATIVE METRICS WERE NOT STATISTICALLY DIFFERENT, OTHER THAN A HIGHER VOLUME OF CONTRAST USE IN THE LARGE FENESTRATION GROUP (99.8 ± 41.6 ML VS. 87.9 ± 32.3 ML, P = 0.0485). FLUOROSCOPY TIME, ESTIMATED BLOOD LOSS, AND EARLY REINTERVENTION RATES (<30 DAYS) WERE NOT STATISTICALLY DIFFERENT AMONG THE 2 GROUPS. REINTERVENTIONS WITHIN 30 DAYS WERE PRIMARILY SECONDARY TO RENAL ARTERY BRANCH OCCLUSIONS, WITH ONLY 1 PATIENT IN THIS COHORT REQUIRING REINTERVENTION FOR AN SMA BRANCH OCCLUSION IN THE SCALLOP GROUP. THE MEAN PROXIMAL SEAL ZONE LENGTH WAS SIGNIFICANTLY GREATER FOR LARGE FENESTRATION VERSUS SCALLOP CONFIGURATIONS (41.7 ± 14.4 MM VS. 19.5 ± 7.9 MM, P < 0.001). ADDITIONALLY, THERE WAS NO DIFFERENCE IN SAC REGRESSION BETWEEN SCALLOPS AND LARGE FENESTRATIONS AT 1 YEAR (10.1 ± 10.9 VS. 11.0 ± 12.1, P = 0.635). SIGNIFICANT SAC REGRESSION, DEFINED AS >5 MM DECREASE, WAS OBSERVED IN 51.4% OF SCALLOPS AND 54.5% OF LARGE FENESTRATIONS AT 1 YEAR (P = 0.126). IMPORTANTLY FOR MIDTERM TECHNICAL SUCCESS, IN THIS COHORT, THERE WERE NO PERSISTING TYPE 1A ENDOLEAKS REQUIRING PROXIMAL NECK REINTERVENTIONS IN EITHER GROUP. ON MULTIVARIATE LOGISTIC REGRESSION ANALYSIS, INCORPORATING CLINICAL, PROCEDURAL, AND ANATOMIC COVARIATES, USE OF A LARGE FENESTRATION FOR THE SMA WAS NOT INDEPENDENTLY ASSOCIATED WITH SAC REGRESSION (ODDS RATIO: 1.01, 95% CONFIDENCE INTERVAL: [0.22-4.73], P = 0.988). (B)(6): 1 PATIENT IN THE SCALLOP GROUP WHO DEVELOPED OCCLUSION OF THE LEFT ILIAC LIMB ON THE FIRST POSTOPERATIVE DAY. THE PATIENT UNDERWENT LEFT ILIOFEMORAL PATCH ANGIOPLASTY WITH EXTERNAL ILIAC ARTERY STENTING AND WAS SUBSEQUENTLY DISCHARGED WITHOUT NEUROLOGIC DEFICITS.
SABINA M. SORONDO 2022, "LARGE FENESTRATIONS VERSUS SCALLOPS FOR THE SUPERIOR MESENTERIC ARTERY DURING FENESTRATED ENDOVASCULAR ANEURYSM REPAIR: DOES IT MATTER?" THE STUDY SOUGHT TO COMPARE MIDTERM CLINICAL OUTCOMES AND SAC REGRESSION OF PATIENTS TREATED WITH THE COOK ZFEN, FROM SEPTEMBER 2021 TO JULY 2021, BETWEEN THE 2 DIFFERENT SMA CONFIGURATIONS: SMA SCALLOP OR LARGE FENESTRATION. 137 ZFEN PATIENTS HAD EITHER A SCALLOP OR A LARGE FENESTRATION FOR THE SMA AS THE PROXIMAL-MOST CONFIGURATION. OF THESE, 72 PATIENTS (52.6%) UNDERWENT REPAIR UTILIZING A SCALLOP CONFIGURATION, AND 65 PATIENTS (47.4%) UNDERWENT A LARGE FENESTRATION. THE PRIMARY OUTCOME OF INTEREST WAS SAC REGRESSION AT 1 YEAR. SECONDARY OUTCOMES INCLUDED PROXIMAL NECK REINTERVENTION RATES, 30-DAY MORTALITY, AND AN OVERALL 3-YEAR SURVIVAL. ALL FIRST POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS (1-30 DAYS) WERE ANALYZED INDEPENDENTLY FOR PROXIMAL SEAL ZONE LENGTHS. PROXIMAL SEAL ZONE LENGTH WAS DEFINED AS THE DISTANCE FROM THE PROXIMAL GRAFT FABRIC TO THE START OF THE ANEURYSM IN LARGE FENESTRATIONS AND THE DISTANCE FROM THE BASE OF THE SCALLOP TO THE ANEURYSM FOR SCALLOP CONFIGURATIONS. ANEURYSM CHARACTERISTICS AND MORPHOLOGY RELATED TO THE NECK DIFFERED SIGNIFICANTLY BETWEEN THE 2 CONFIGURATIONS. WHILE MAXIMUM ANEURYSMSIZE DID NOT DIFFER SIGNIFICANTLY BETWEEN THE SCALLOP AND LARGE FENESTRATION GROUPS (61.6 ± 13.2 MM VS. 63.7 ± 13.4 MM, P = 0.33), THE SCALLOP GROUP HAD A SIGNIFICANTLY SMALLER INFRARENAL NECK DIAMETER (25.0 ± 5.32 VS. 26.9 ± 6.26, P = 0.044), LARGER SUPRARENAL NECK ANGULATION (24.3 ± 19.0 VS. 16.7 ± 11.1, P = 0.003), AND SMALLER DEVICE DIAMETER (29.5 ± 3.24 VS. 31.5 ± 3.23, P = 0.0002) AS COMPARED TO THE LARGE FENESTRATION GROUP. WITH REGARDS TO PERIOPERATIVE OUTCOMES, OPERATIVE METRICS WERE NOT STATISTICALLY DIFFERENT, OTHER THAN A HIGHER VOLUME OF CONTRAST USE IN THE LARGE FENESTRATION GROUP (99.8 ± 41.6 ML VS. 87.9 ± 32.3 ML, P = 0.0485). FLUOROSCOPY TIME, ESTIMATED BLOOD LOSS, AND EARLY REINTERVENTION RATES (<30 DAYS) WERE NOT STATISTICALLY DIFFERENT AMONG THE 2 GROUPS. REINTERVENTIONS WITHIN 30 DAYS WERE PRIMARILY SECONDARY TO RENAL ARTERY BRANCH OCCLUSIONS, WITH ONLY 1 PATIENT IN THIS COHORT REQUIRING REINTERVENTION FOR AN SMA BRANCH OCCLUSION IN THE SCALLOP GROUP. THE MEAN PROXIMAL SEAL ZONE LENGTH WAS SIGNIFICANTLY GREATER FOR LARGE FENESTRATION VERSUS SCALLOP CONFIGURATIONS (41.7 ± 14.4 MM VS. 19.5 ± 7.9 MM, P < 0.001). ADDITIONALLY, THERE WAS NO DIFFERENCE IN SAC REGRESSION BETWEEN SCALLOPS AND LARGE FENESTRATIONS AT 1 YEAR (10.1 ± 10.9 VS. 11.0 ± 12.1, P = 0.635). SIGNIFICANT SAC REGRESSION, DEFINED AS >5 MM DECREASE, WAS OBSERVED IN 51.4% OF SCALLOPS AND 54.5% OF LARGE FENESTRATIONS AT 1 YEAR (P = 0.126). IMPORTANTLY FOR MIDTERM TECHNICAL SUCCESS, IN THIS COHORT, THERE WERE NO PERSISTING TYPE 1A ENDOLEAKS REQUIRING PROXIMAL NECK REINTERVENTIONS IN EITHER GROUP. ON MULTIVARIATE LOGISTIC REGRESSION ANALYSIS, INCORPORATING CLINICAL, PROCEDURAL, AND ANATOMIC COVARIATES, USE OF A LARGE FENESTRATION FOR THE SMA WAS NOT INDEPENDENTLY ASSOCIATED WITH SAC REGRESSION (ODDS RATIO: 1.01, 95% CONFIDENCE INTERVAL: [0.22-4.73], P = 0.988). (B)(6): 1 PATIENT IN THE SCALLOP GROUP WHO DEVELOPED OCCLUSION OF THE LEFT ILIAC LIMB ON THE FIRST POSTOPERATIVE DAY. THE PATIENT UNDERWENT LEFT ILIOFEMORAL PATCH ANGIOPLASTY WITH EXTERNAL ILIAC ARTERY STENTING AND WAS SUBSEQUENTLY DISCHARGED WITHOUT NEUROLOGIC DEFICITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167387 | ZENITH FENESTRATED GRAFT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |