ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2022-00028
- Event Type
- Injury
- Date Received
- November 29, 2022
- Report Date
- February 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
NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. NO IMAGING WAS SUPPLIED TO ASSIST THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED. MEDICAL DIRECTOR REVIEWED THE INFORMATION AVAILABLE AND STATED THE FOLLOWING: "ONE OF THE PROBLEMS I HAVE WITH DOING A ¿BLANKET¿ ASSESSMENT OF ALL COMPLAINTS IS THAT WE DON¿T HAVE ANY DETAILS FOR MOST OF THEM. THE STENOSIS AND OCCLUSION EVENTS - THEY COULD BE ANYTHING THAT WAS JUST NOTED AND LISTED, BUT OF LITTLE OR NO CLINICAL SIGNIFICANCE". WORK ORDER REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE COMPLAINT DEVICES STATES: "THE LONG-TERM PERFORMANCE OF FENESTRATED ENDOVASCULAR GRAFTS, INCLUDING THE STENTS PLACED IN FENESTRATIONS/SCALLOPS, 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 ANEURYSMS, CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT, OR STENOSIS/OCCLUSION OF VESSELS ACCOMMODATED BY FENESTRATIONS) SHOULD RECEIVE ENHANCED FOLLOW-UP". BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE OF THE STENOSIS WAS NOT ABLE TO BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE STENOSIS WAS DUE TO: - PATIENT RELATED FACTORS (MAY BE PRE-EXISTING DUE TO ANEURYSM). - INAPPROPRIATE PATIENT SELECTION. - PROCEDURAL FACTORS.
FROM A JOURNAL ARTICLE COVERING RENAL STENT STENOSIS FOLLOWING ZFEN IMPLANT 12 PATIENTS: PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LARGE DIAMETER (LD) GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE NORMAL DIAMETER (ND) GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA [COMPUTER TOMOGRAPHY ANGIOGRAM] AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LARGE DIAMETER (LD) GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LARGE DIAMETER (LD) GROUP. LARGE DIAMETER (LD) GROUP 19.05% +/- 18.25%. NORMAL DIAMETER (ND) GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 58.5 MM +/- 9.6 MM. AAA DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 61.0 MM +/- 17.4 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 23.4 MM +/- 3.2 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 30.1 MM +/- 5.3 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 4.7 MM +/- 3.44 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 2.6 MM +/- 2.9 MM. INFRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 31.7 DEGREES +/- 19.4 DEGREES. INFRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 21.5 DEGREES +/- 12.1 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 24.8 DEGREES +/- 18.9 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 16.5 DEGREES +/-15.8 DEGREES. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 18. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 8. 12 PATIENTS (5 ND GROUP, 7 LARGE DIAMETER (LD) GROUP) HAD RENAL STENT STENOSIS THAT REQUIRED REINTERVENTION.
FROM A JOURNAL ARTICLE COVERING RENAL STENT STENOSIS FOLLOWING ZFEN IMPLANT 12 PATIENTS: PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LARGE DIAMETER (LD) GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE NORMAL DIAMETER (ND) GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA [COMPUTER TOMOGRAPHY ANGIOGRAM] AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LARGE DIAMETER (LD) GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LARGE DIAMETER (LD) GROUP. LARGE DIAMETER (LD) GROUP 19.05% +/- 18.25%. NORMAL DIAMETER (ND) GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 58.5 MM +/- 9.6 MM. AAA DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 61.0 MM +/- 17.4 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 23.4 MM +/- 3.2 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 30.1 MM +/- 5.3 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 4.7 MM +/- 3.44 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 2.6 MM +/- 2.9 MM. INFRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 31.7 DEGREES +/- 19.4 DEGREES. INFRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 21.5 DEGREES +/- 12.1 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 24.8 DEGREES +/- 18.9 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 16.5 DEGREES +/-15.8 DEGREES. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE NORMAL DIAMETER (ND) GROUP: 18. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LARGE DIAMETER (LD) GROUP: 8. 12 PATIENTS (5 ND GROUP, 7 LARGE DIAMETER (LD) GROUP) HAD RENAL STENT STENOSIS THAT REQUIRED REINTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1960186 | 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 |