ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2023-00035
- Event Type
- Injury
- Date Received
- June 1, 2023
- Report Date
- August 21, 2023
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS RECEIVED. NO IMAGING WAS RECEIVED TO ASSIST THE INVESTIGATION. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) LIKELY SUPPLIED WITH THE DEVICE (AS THE LOT NUMBER IS UNKNOWN, THE IFU CURRENTLY SUPPLIED WITH ZFEN DEVICES WAS REVIEWED) FOUND TO CONTAIN APPROPRIATE WARNINGS, PRECAUTIONS, AND INSTRUCTIONS TO THE USER, INCLUDING: 5 POTENTIAL ADVERSE EVENTS USE OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT POSES THE FOLLOWING POTENTIAL RISKS IN ADDITION TO THOSE ASSOCIATED WITH USE OF A STANDARD ZENITH ENDOVASCULAR GRAFT: ORGAN IMPAIRMENT/LOSS DUE TO SIDE-BRANCH VESSEL OCCLUSION (IN PARTICULAR, RENAL AND/OR GASTROINTESTINAL IMPAIRMENT/LOSS) OTHER ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM 7 PATIENT COUNSELING INFORMATION THE LONG-TERM PERFORMANCE AND SAFETY OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED AS A RESULT, LIFE-LONG, REGULAR FOLLOW-UP MUST BE UNDERTAKEN IN ALL PATIENTS TO ASSESS THE ONGOING PERFORMANCE OF THE ZENITH FENESTRATED AAA 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THIS IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES INCLUDE: - ROUGH SURFACE PRONE TO THROMBUS FORMATION - INADEQUATE MEDICATION OF PATIENT WITH ANTICOAGULANTS - PATIENT FACTORS SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION MAY BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUPPLIED. EVENT INFORMAOINT TAKEN FROM REVIEW OF A JOURNAL ARTICLE ARTICLE: THE JOURNAL OF CARDIOVASCULAR SURGERY 2020 OCTOBER;61(5):596-603 DOI: 10.23736/S0021-9509.19.11052-X
LITERATURE ARTICLE: THE JOURNAL OF CARDIOVASCULAR SURGERY 2020 OCTOBER;61(5):596-603. DOI: 10.23736/S0021-9509.19.11052-X .
RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR (EVAR) FOR TREATMENT OF AAA FROM 1ST JANUARY 2008 TO 31ST DECEMBER 2017 IDENTIFIED FROM THE NATIONAL VASCULAR REGISTRY (NVR¿ ANAEROBIC THRESHOLD AS AN INDEPENDENT PREDICTOR OF MIDTERM SURVIVAL FOLLOWING ELECTIVE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM. DAWKINS, C., ET AL., 2020. FOUR HUNDRED AND THIRTY PATIENTS UNDERWENT ELECTIVE EVAR FOR REPAIR OF AAA OF WHOM 389 (90.5%) WERE MEN AND 41 (9.5%) WERE WOMEN. THE MEDIAN AGE OF PATIENTS WAS 76 YEARS (RANGE: 53-91). THE MEDIAN AAA DIAMETER AT THE TIME OF REPAIR WAS 61 MM (RANGE: 45-115). IN ADDITION TO THE STUDY POPULATION, BETWEEN JANUARY 1ST, 2008 AND DECEMBER 31ST, 2017, 238 PATIENTS (216 MEN, 90.8%, 22 WOMEN, 9.2%) WITH A MEAN AGE OF 69.71±7.42 YEARS UNDERWENT ELECTIVE OPEN REPAIR OF AAA. PERIPROCEDURAL 30- DAY MORTALITY OF THESE PATIENTS WAS 1.68% (FOUR PATIENTS). INTER-OBSERVER AGREEMENT FOR CLASSIFICATION OF AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE CONSERVATIVE IFU FOR A STANDARD ENDOVASCULAR DEVICE WAS EXCELLENT (¿=0.83). A SIMILARLY GOOD INTER-OBSERVER CORRELATION WAS OBSERVED IN CLASSIFYING AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE LIBERAL IFU FOR STANDARD EVAR, (¿=0.79). THREE HUNDRED AND THIRTY-SIX PATIENTS (78.1%) HAD AORTIC ANATOMY WHICH FULFILLED A CONSERVATIVE IFU FOR STANDARD EVAR, 42 (9.8%) FULFILLED A LIBERAL INTERPRETATION OF IFU FOR EVAR AND 52 (12.1%) DID NOT MEET THE IFU FOR STANDARD INFRA RENAL EVAR. A VARIETY OF ENDOVASCULAR DEVICES WERE USED TO TREAT THESE ABDOMINAL AORTIC ANEURYSMS. EACH CASE WAS PLANNED TO MATCH THE IFU OF THE DEVICE USED. OF THE 430 PATIENTS TREATED, 374 UNDERWENT INFRA-RENAL EVAR (N.=371) OR EVAS (N.=3) AND 56 UNDERWENT COMPLEX EVAR TO EXTEND THE SEAL ZONE ABOVE THE RENAL ARTERIES (FENESTRATED EVAR OR BRANCHED STENT GRAFTS). MEDIAN DURATION OF RADIOLOGICAL FOLLOW-UP WAS 1630 DAYS (RANGE: 356-3892 DAYS). EACH PATIENT UNDERWENT A MEDIAN OF 5 (RANGE: 1-12) RADIOLOGICAL FOLLOW-UP CYCLES. THE INCIDENCE OF TYPE I ENDOLEAK AND STENT GRAFT MIGRATION DURING THE FOLLOW-UP PERIOD WAS 22 (5%) AND 13 (3%), RESPECTIVELY. IN FOUR PATIENTS, TYPE I ENDOLEAKS HAD OCCURRED DUE TO DEVICE MIGRATION; IN ADDITION, SIX GRAFT LIMBS AND TWO GRAFT BODIES HAD THROMBOSED. ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC GROW BY IN EXCESS OF 5-MM FREEDOM FROM AAA RUPTURE AT 5 YEARS WAS 98.1% (STANDARD EVAR: 97.8%, COMPLEX EVAR: 98.2%). ONE GRAFT WAS EXPLANTED DUE TO INFECTION. THE CUMULATIVE RE-INTERVENTION RATE OVER THE DURATION OF FOLLOW-UP WAS 3.45% PER PERSON-YEARS, WHILST 5-YEAR RE-INTERVENTION FREE SURVIVAL WAS 84.3%. A TOTAL OF SIXTY-ONE RE-INTERVENTIONS WERE PERFORMED IN 59 PATIENTS (STANDARD EVAR: N.=52, COMPLEX EVAR: N.=7). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN SURVIVAL, FREEDOM FROM RUPTURE OR RE-INTERVENTION BETWEEN PATIENTS WHO UNDERWENT STANDARD EVAR AND THOSE WHO UNDERWENT COMPLEX EVAR. USE OF COOK MANUFACTURED DEVICES: ZENITH FLEX COOK MEDICAL EUROPE X 123 (28.60%) ALPHA COOK MEDICAL EUROPE X 7 (1.63%) ZENITH T BRANCH STENT¿ (COMPLEX) COOK MEDICAL EUROPE X 2 (0.47%) ZENITH FENESTRATED STENT¿ (COMPLEX) COOK MEDICAL AUSTRALIA X 51 (11.86%) A TOTAL OF 183 COOK MEDICAL DEVICES WERE IMPLANTED. (42.657% OF ALL DEVICES USED). 51 OF THOSE DEVICES WERE MANUFACTURED BY WCA. OTHER MANUFACTURERS DEVICES: EXCLUDER¿ GORE® X 168 (39.07%) ENDURANT II¿ MEDTRONIC® X 47 (10.93%) TALENT¿ MEDTRONIC® X 6 (1.40%) AORFIX¿ LOMBARD® MEDICAL X 12 (2.79%) ANACONDA¿ VASCUTEK® X 6 (1.40%) OVATION® ENDOLOGIX® X 1 (0.23%) NELLIX ® ENDOLOGIX® X 3 (0.70%) ANACONDA¿ FENESTRATED STENT (COMPLEX) VASCUTEK® X 2 (0.70%) ENDURANT II¿ CHIMNEY CONFIGURATION (COMPLEX) MEDTRONIC® X 1 (0.23%) A TOTAL OF 246 DEVICES MANUFACTURED BY OTHER COMPANIES WERE IMPLANTED. 57.343% OF ALL DEVICES USED. THIS PR397450: THROMBOSIS DURING THE FOLLOW-UP PERIOD. TWO GRAFT MAIN BODIES HAD THROMBOSED, AND SIX GRAFT LIMBS HAD THROMBOSED: - GRAFT THROMBOSIS (MAIN BODY) REQUIRING AXILLO-BIFEMORAL BYPASS IN 1 PATIENT (1.75%) - GRAFT THROMBOSIS (MAIN BODY) REQUIRING GRAFT THROMBECTOMY IN 1 PATIENT (1.75%) - ILIAC LIMB THROMBOSIS REQUIRING FEMORO-FEMORAL CROSS OVER IN 2 PATIENTS (3.6%) - LIMB ANGULATION/THROMBUS WITHIN LIMB REQUIRING LIMB RELINING IN 4 PATIENTS (7.0%)
RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR (EVAR) FOR TREATMENT OF AAA FROM (B)(6) 2008 TO (B)(6) 2017 IDENTIFIED FROM THE NATIONAL VASCULAR REGISTRY (NVR¿ ANAEROBIC THRESHOLD AS AN INDEPENDENT PREDICTOR OF MIDTERM SURVIVAL FOLLOWING ELECTIVE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM. DAWKINS, C., ET AL., 2020. FOUR HUNDRED AND THIRTY PATIENTS UNDERWENT ELECTIVE EVAR FOR REPAIR OF AAA OF WHOM 389 (90.5%) WERE MEN AND 41 (9.5%) WERE WOMEN. THE MEDIAN AGE OF PATIENTS WAS 76 YEARS (RANGE: 53-91). THE MEDIAN AAA DIAMETER AT THE TIME OF REPAIR WAS 61 MM (RANGE: 45-115). IN ADDITION TO THE STUDY POPULATION, BETWEEN (B)(6) 2008 AND (B)(6) 2017, 238 PATIENTS (216 MEN, 90.8%, 22 WOMEN, 9.2%) WITH A MEAN AGE OF 69.71±7.42 YEARS UNDERWENT ELECTIVE OPEN REPAIR OF AAA. PERIPROCEDURAL 30- DAY MORTALITY OF THESE PATIENTS WAS 1.68% (FOUR PATIENTS). INTER-OBSERVER AGREEMENT FOR CLASSIFICATION OF AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE CONSERVATIVE IFU FOR A STANDARD ENDOVASCULAR DEVICE WAS EXCELLENT (¿=0.83). A SIMILARLY GOOD INTER-OBSERVER CORRELATION WAS OBSERVED IN CLASSIFYING AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE LIBERAL IFU FOR STANDARD EVAR, (=0.79). THREE HUNDRED AND THIRTY-SIX PATIENTS (78.1%) HAD AORTIC ANATOMY WHICH FULFILLED A CONSERVATIVE IFU FOR STANDARD EVAR, 42 (9.8%) FULFILLED A LIBERAL INTERPRETATION OF IFU FOR EVAR AND 52 (12.1%) DID NOT MEET THE IFU FOR STANDARD INFRA RENAL EVAR. A VARIETY OF ENDOVASCULAR DEVICES WERE USED TO TREAT THESE ABDOMINAL AORTIC ANEURYSMS. EACH CASE WAS PLANNED TO MATCH THE IFU OF THE DEVICE USED. OF THE 430 PATIENTS TREATED, 374 UNDERWENT INFRA-RENAL EVAR (N.=371) OR EVAS (N.=3) AND 56 UNDERWENT COMPLEX EVAR TO EXTEND THE SEAL ZONE ABOVE THE RENAL ARTERIES (FENESTRATED EVAR OR BRANCHED STENT GRAFTS). MEDIAN DURATION OF RADIOLOGICAL FOLLOW-UP WAS 1630 DAYS (RANGE: 356-3892 DAYS). EACH PATIENT UNDERWENT A MEDIAN OF 5 (RANGE: 1-12) RADIOLOGICAL FOLLOW-UP CYCLES. THE INCIDENCE OF TYPE I ENDOLEAK AND STENT GRAFT MIGRATION DURING THE FOLLOW-UP PERIOD WAS 22 (5%) AND 13 (3%), RESPECTIVELY. IN FOUR PATIENTS, TYPE I ENDOLEAKS HAD OCCURRED DUE TO DEVICE MIGRATION; IN ADDITION, SIX GRAFT LIMBS AND TWO GRAFT BODIES HAD THROMBOSED. ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC GROW BY IN EXCESS OF 5-MM FREEDOM FROM AAA RUPTURE AT 5 YEARS WAS 98.1% (STANDARD EVAR: 97.8%, COMPLEX EVAR: 98.2%). ONE GRAFT WAS EXPLANTED DUE TO INFECTION. THE CUMULATIVE RE-INTERVENTION RATE OVER THE DURATION OF FOLLOW-UP WAS 3.45% PER PERSON-YEARS, WHILST 5-YEAR RE-INTERVENTION FREE SURVIVAL WAS 84.3%. A TOTAL OF SIXTY-ONE RE-INTERVENTIONS WERE PERFORMED IN 59 PATIENTS (STANDARD EVAR: N.=52, COMPLEX EVAR: N.=7). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN SURVIVAL, FREEDOM FROM RUPTURE OR RE-INTERVENTION BETWEEN PATIENTS WHO UNDERWENT STANDARD EVAR AND THOSE WHO UNDERWENT COMPLEX EVAR. USE OF COOK MANUFACTURED DEVICES: ZENITH FLEX COOK MEDICAL EUROPE X 123 (28.60%). ALPHA COOK MEDICAL EUROPE X 7 (1.63%). ZENITH T BRANCH STENT¿ (COMPLEX) COOK MEDICAL EUROPE X 2 (0.47%) . ZENITH FENESTRATED STENT¿ (COMPLEX) COOK MEDICAL AUSTRALIA X 51 (11.86%). A TOTAL OF 183 COOK MEDICAL DEVICES WERE IMPLANTED. (42.657% OF ALL DEVICES USED). 51 OF THOSE DEVICES WERE MANUFACTURED BY WCA. OTHER MANUFACTURERS DEVICES: EXCLUDER¿ GORE® X 168 (39.07%) . ENDURANT II¿ MEDTRONIC® X 47 (10.93%) . TALENT¿ MEDTRONIC® X 6 (1.40%) . AORFIX¿ LOMBARD® MEDICAL X 12 (2.79%). ANACONDA¿ VASCUTEK® X 6 (1.40%) . OVATION® ENDOLOGIX® X 1 (0.23%) . NELLIX ® ENDOLOGIX® X 3 (0.70%). ANACONDA¿ FENESTRATED STENT (COMPLEX) VASCUTEK® X 2 (0.70%) . ENDURANT II¿ CHIMNEY CONFIGURATION (COMPLEX) MEDTRONIC® X 1 (0.23%). A TOTAL OF 246 DEVICES MANUFACTURED BY OTHER COMPANIES WERE IMPLANTED. 57.343% OF ALL DEVICES USED. THIS (B)(4): THROMBOSIS DURING THE FOLLOW-UP PERIOD. TWO GRAFT MAIN BODIES HAD THROMBOSED, AND SIX GRAFT LIMBS HAD THROMBOSED: GRAFT THROMBOSIS (MAIN BODY) REQUIRING AXILLO-BIFEMORAL BYPASS IN 1 PATIENT (1.75%). GRAFT THROMBOSIS (MAIN BODY) REQUIRING GRAFT THROMBECTOMY IN 1 PATIENT (1.75%). ILIAC LIMB THROMBOSIS REQUIRING FEMORO-FEMORAL CROSS OVER IN 2 PATIENTS (3.6%). LIMB ANGULATION/THROMBUS WITHIN LIMB REQUIRING LIMB RELINING IN 4 PATIENTS (7.0%).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31561 | ZENITH FENESTRATED GRAFT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |