AFX
Report
- Report Number
- 2031527-2018-00487
- Event Type
- Injury
- Date Received
- May 29, 2018
- Date of Event
- December 11, 2017
- Report Date
- May 29, 2018
- Manufacturer
- ENDOLOGIX INC.
- Product Code
- MIH
- UDI-DI
- 0081009013620
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
AT THE COMPLETION OF THE CLINICAL EVALUATION AND BASED ON THE INFORMATION RECEIVED, THERE WAS SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS: ENDOLEAKS 1A AND 2, AND ENDOVASCULAR RELINING. THERE WAS SUBSTANTIAL EVIDENCE TO REFUTE THE FOLLOWING REPORTED EVENTS: ENDOLEAK 3A, RATHER THERE WAS AN ENDOLEAK 3B NOTED ONE MONTH POST-IMPLANT (LEFT LATERAL DISTAL NEAR BIFURCATION). ADDITIONAL FINDINGS INCLUDE SAC GROWTH (8MM/27M) AT 27 MONTHS POST-IMPLANT. THE MOST LIKELY CAUSE OF THE PROXIMAL LOSS OF SEAL WAS THE HOSTILE AORTIC NECK ANATOMY AND THE PRESENCE OF A PATENT, LOW ACCESSORY RENAL ARTERY. THE MOST LIKELY CAUSE OF THE COMPROMISED STENT GRAFT INTEGRITY (BREACHED) OF THE MAIN BODY STENT WAS THE USE OF STRATA MATERIAL. PROCEDURE-RELATED HARMS INCLUDED A TYPE 2 ENDOLEAK. THE FINAL PATIENT DISPOSITION COULD NOT BE DETERMINED DUE TO THE LACK OF MEDICAL INFORMATION SURROUNDING THE IMPLANT AND REPAIR EVENTS. THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. REFERENCE MANUFACTURER REPORT NUMBER 2031527-2018-00192 FOR FOLLOW-UP REPORT 001 TO AFX BIFURCATED STENT GRAFT, LOT # 1251692-025.THIS REPORT IS TO ADDRESS THE TYPE 1A ENDOLEAK FOUND AT CLINICAL EVALUATION TO AFX VELA SUPRARENAL, LOT # 1210034-013. A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE 3B ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE 3B ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE JULY 2014. THE TYPE 3B ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT 2.5%. SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE 3B ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO <0.2%.
AT THE COMPLETION OF THE CLINICAL EVALUATION AND BASED ON THE INFORMATION RECEIVED, THERE WAS SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS: ENDOLEAKS 1A AND 2, AND ENDOVASCULAR RELINING. THERE WAS SUBSTANTIAL EVIDENCE TO REFUTE THE FOLLOWING REPORTED EVENTS: ENDOLEAK 3A, RATHER THERE WAS AN ENDOLEAK 3B NOTED ONE MONTH POST-IMPLANT (LEFT LATERAL DISTAL NEAR BIFURCATION). ADDITIONAL FINDINGS INCLUDE SAC GROWTH (8 MM/27M) AT 27 MONTHS POST-IMPLANT. THE MOST LIKELY CAUSE OF THE PROXIMAL LOSS OF SEAL WAS THE HOSTILE AORTIC NECK ANATOMY AND THE PRESENCE OF A PATENT, LOW ACCESSORY RENAL ARTERY. THE MOST LIKELY CAUSE OF THE COMPROMISED STENT GRAFT INTEGRITY (BREACHED) OF THE MAIN BODY STENT WAS THE USE OF STRATA MATERIAL. PROCEDURE-RELATED HARMS INCLUDED A TYPE 2 ENDOLEAK. THE FINAL PATIENT DISPOSITION COULD NOT BE DETERMINED DUE TO THE LACK OF MEDICAL INFORMATION SURROUNDING THE IMPLANT AND REPAIR EVENTS. THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. REFERENCE MANUFACTURER REPORT NUMBER 2031527-2018-00192 FOR FOLLOW-UP REPORT 001 TO AFX BIFURCATED STENT GRAFT, LOT # 1251692-025. THIS REPORT IS TO ADDRESS THE TYPE 1A ENDOLEAK FOUND AT CLINICAL EVALUATION TO AFX VELA SUPRARENAL, LOT # 1210034-013. A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE 3B ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE 3B ENDOLEAK EVENTS; UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE (B)(6) 2014. THE TYPE 3B ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT (B)(4). SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE 3B ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO <0.2%.
ENDOLOGIX BECAME AWARE OF A RE-INTERVENTION ON (B)(6) 2017 AS REPORTED BY PHYSICIAN (B)(6). AS THE DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE (B)(6) 2017 WAS USED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015 BY THE REPORTING PHYSICIAN. ON AN UNKNOWN DATE, THE PHYSICIAN SUSPECTED A 3A ENDOLEAK, WHICH WAS NOT CONFIRMED, AND POSSIBLE BILLOWING WITH A TYPE 2 ENDOLEAK. THE PATIENT WAS ASYMPTOMATIC. DURING RE-INTERVENTION, THE PATIENT WAS RELINED BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND ONE ADDITIONAL VELA SUPRARENAL ON (B)(6) 2017 BY PHYSICIAN (B)(6).
ENDOLOGIX BECAME AWARE OF A RE-INTERVENTION ON (B)(6) 2017 AS REPORTED BY PHYSICIAN (B)(6). AS THE DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE (B)(6) 2017 WAS USED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015 BY THE REPORTING PHYSICIAN. ON AN UNKNOWN DATE, THE PHYSICIAN SUSPECTED A 3A ENDOLEAK, WHICH WAS NOT CONFIRMED, AND POSSIBLE BILLOWING WITH A TYPE 2 ENDOLEAK. THE PATIENT WAS ASYMPTOMATIC. DURING RE-INTERVENTION, THE PATIENT WAS RELINED BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND ONE ADDITIONAL VELA SUPRARENAL ON (B)(6) 2017 BY PHYSICIAN (B)(6).
AT THE COMPLETION OF THE CLINICAL EVALUATION AND BASED ON THE INFORMATION RECEIVED, THERE WAS SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS: ENDOLEAKS 1A AND 2, AND ENDOVASCULAR RELINING. THERE WAS SUBSTANTIAL EVIDENCE TO REFUTE THE FOLLOWING REPORTED EVENTS: ENDOLEAK 3A, RATHER THERE WAS AN ENDOLEAK 3B NOTED ONE MONTH POST-IMPLANT (LEFT LATERAL DISTAL NEAR BIFURCATION). ADDITIONAL FINDINGS INCLUDE SAC GROWTH (8MM/27M) AT 27 MONTHS POST-IMPLANT. THE MOST LIKELY CAUSE OF THE PROXIMAL LOSS OF SEAL WAS THE HOSTILE AORTIC NECK ANATOMY AND THE PRESENCE OF A PATENT, LOW ACCESSORY RENAL ARTERY. THE MOST LIKELY CAUSE OF THE COMPROMISED STENT GRAFT INTEGRITY (BREACHED) OF THE MAIN BODY STENT WAS THE USE OF STRATA MATERIAL. PROCEDURE-RELATED HARMS INCLUDED A TYPE 2 ENDOLEAK. THE FINAL PATIENT DISPOSITION COULD NOT BE DETERMINED DUE TO THE LACK OF MEDICAL INFORMATION SURROUNDING THE IMPLANT AND REPAIR EVENTS. THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. REFERENCE MANUFACTURER REPORT NUMBER 2031527-2018-00192 FOR FOLLOW-UP REPORT 001 TO AFX BIFURCATED STENT GRAFT, LOT # 1251692-025. THIS REPORT IS TO ADDRESS THE TYPE 1A ENDOLEAK FOUND AT CLINICAL EVALUATION TO AFX VELA SUPRARENAL, LOT # 1210034-013. A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE 3B ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE 3B ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE JULY 2014. THE TYPE 3B ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT (B)(4). SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE 3B ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO (B)(4).
ENDOLOGIX BECAME AWARE OF A RE-INTERVENTION ON (B)(6) 2017 AS REPORTED BY PHYSICIAN (B)(6). AS THE DATE OF EVENT IS UNKNOWN, THE BEST ESTIMATE (B)(6) 2017 WAS USED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON (B)(6) 2015 BY THE REPORTING PHYSICIAN. ON AN UNKNOWN DATE, THE PHYSICIAN SUSPECTED A 3A ENDOLEAK, WHICH WAS NOT CONFIRMED, AND POSSIBLE BILLOWING WITH A TYPE 2 ENDOLEAK. THE PATIENT WAS ASYMPTOMATIC. DURING RE-INTERVENTION, THE PATIENT WAS RELINED BY IMPLANTING AN AFX2 BIFURCATED STENT GRAFT AND ONE ADDITIONAL VELA SUPRARENAL ON (B)(6) 2017 BY PHYSICIAN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394062 | AFX | VELA SUPRARENAL | MIH | ENDOLOGIX INC. | A25-25/C95-O20 V | 1210034-013 | 0081009013620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | AFX-BIFURCATED STENT GRAFT - LOT 1251692-025| AFX-BIFURCATED STENT GRAFT - LOT 1251692-025 |