ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2022-00033
- Event Type
- Injury
- Date Received
- November 29, 2022
- Report Date
- April 11, 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. NO ADDITIONAL INFORMATION WAS RECEIVED, DESPITE THREE REQUESTS BEING MADE. 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". A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) SUPPLIED WITH THE COMPLAINT DEVICE 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." RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G. ARTERY STENOSIS OR OCCLUSION, CONTRAST TOXICITY, INFARCT, INSUFFICIENCY, FAILURE) ARE LISTED AS POTENTIAL ADVERSE EVENTS. BASED ON THE INFORMATION AVAILABLE A DEFINITIVE ROOT CAUSE FOR THE OCCLUSION COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE OCCLUSION COULD BE DUE TO: 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 AND/OR PROCEDURAL FACTORS.
FROM A JOURNAL ARTICLE COVERING SMA STENT OCCLUSION FOLLOWING ZFEN IMPLANT: 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. 1 PATIENT (NORMAL DIAMETER (ND) GROUP) HAD SMA STENT OCCLUSION THAT REQUIRED REINTERVENTION.
FROM A JOURNAL ARTICLE COVERING SMA STENT OCCLUSION FOLLOWING ZFEN IMPLANT: 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. 1 PATIENT (NORMAL DIAMETER (ND) GROUP) HAD SMA STENT OCCLUSION THAT REQUIRED REINTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1852125 | 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 |