AFX2
Report
- Report Number
- 2031527-2023-00071
- Event Type
- Death
- Date Received
- May 15, 2023
- Date of Event
- April 23, 2023
- Report Date
- April 24, 2023
- Manufacturer
- ENDOLOGIX
- Product Code
- MIH
- UDI-DI
- 00818009014399
- PMA / PMN Number
- P040002
- Removal / Correction Number
- Z-0007-2019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY A CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX2. CORRECTIONS: B2: OUTCOMES ATTRIBUTED TO AE - UPDATED. B5: DESCRIBE EVENT OR PROBLEM - UPDATED. G3: AWARENESS DATE - UPDATED. H1: TYPE OF REPORTABLE EVENT - UPDATED. H6: HEALTH EFFECT - IMPACT CODE - REMOVE 4614.
THE REPORTED INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. AN EVALUATION OF THE MANUFACTURING RECORD WAS COMPLETED. A REVIEW OF THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION SHOWS THE DEVICE TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT COULD NOT BE COMPLETED. NO MEDICAL RECORDS NOR MEDICAL IMAGING RELEVANT TO THE REPORTED ADVERSE EVENT/INCIDENT WAS RECEIVED BY ENDOLOGIX. THE USER FACILITY WAS UNABLE TO PROVIDE THIS INFORMATION. DUE TO THE ABSENCE OF MEDICAL RECORDS AND MEDICAL IMAGING DEVICE, USE, PROCEDURE, AND/OR ANATOMY RELATEDNESS TO THIS INCIDENT COULD NOT BE EVALUATED. THE FINAL PATIENT STATUS WAS REPORTED TO BE DEATH DUE TO COMPLICATIONS RELATED TO THE CAR ACCIDENT; HOWEVER, ENDOLOGIX WAS UNABLE TO CONFIRM THIS AS MEDICAL RECORDS NOR IMAGING WERE NOT PROVIDED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR INCIDENTS. DEVICE ITERATION IS AFX2.
THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY A CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX2. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.
THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY THREE (3) YEARS POST-INITIAL PROCEDURE, THE PATIENT WAS IN A CAR ACCIDENT EXPERIENCING INTERNAL TRAUMA. A POSSIBLE TYPE 3B ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND TWO (2) OVATION IX EXTENDER. THE TYPE 3B ENDOLEAK WAS REPORTED TO BE SEALED. REFERENCE MFR. REPORT # 2031527-2022-00124. NOW, APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION, THE PATIENT HAS BEEN IN A CAR ACCIDENT AND THERE IS A POSSIBLE TYPE 3B ENDOLEAK. REINTERVENTION HAS BEEN SCHEDULED. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE REINTERVENTION WAS CANCELLED AS THE PATIENT PASSED AWAY ON AN UNKNOWN DATE DUE TO COMPLICATIONS FROM THE CAR ACCIDENT.
THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY THREE (3) YEARS POST-INITIAL PROCEDURE, THE PATIENT WAS IN A CAR ACCIDENT EXPERIENCING INTERNAL TRAUMA. A POSSIBLE TYPE 3B ENDOLEAK WAS IDENTIFIED. REINTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA INFRARENAL, AND TWO (2) OVATION IX EXTENDER. THE TYPE 3B ENDOLEAK WAS REPORTED TO BE SEALED. REFERENCE MFR. REPORT # 2031527-2022-00124. NOW, APPROXIMATELY ONE (1) YEAR POST-REINTERVENTION, THE PATIENT HAS BEEN IN A CAR ACCIDENT AND THERE IS A POSSIBLE TYPE 3B ENDOLEAK. REINTERVENTION HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 915777 | AFX2 | BIFURCATED STENT GRAFT | MIH | ENDOLOGIX | BEA28-120/I20-40 | 2496063010 | 00818009014399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Death| O | AFX VELA INFRARENAL (LN 2494729004)| AFX VELA SUPRARENAL (LN 1820520004)| AFX2 BIFURCATED STENT GRAFT (LN 1984019-009)| OVATION IX EXTENDER (LN FS052418-46)| OVATION IX EXTENDER (LN FS111521-24)| OVATION IX EXTENDER (LN FS111721-47) |