MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-110/I20-30

Device Problems Collapse (1099); Patient-Device Incompatibility (2682); Insufficient Information (3190); Migration (4003)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208)

Event Date 07/25/2021

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented in the emergency room with back pain.A type 3a endoleak and possible type 1b endoleak were identified.The physician elected to implant a bifurcated stent graft, suprarenal aortic extension and an infrarenal aortic extension to resolve this event.The patient was reported as stable post secondary procedure.

Manufacturer Narrative

The reported adverse event/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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiia endoleak complaint was refuted, rather there were bilateral type ib endoleaks, a type ia endoleak and a type ii endoleak (lumbar).This is not consistent with the reported adverse event/incident.Procedure related harms for this complaint could not be determined with the medical records available for review.Additionally, the clinical evaluation also shows that there was evidence to reasonably suggest buckling of the proximal extension, migration of the proximal extension, sac growth of 34.5mm and an aortic rupture occurred that were not included in the event as reported.The most likely causation for this event was anatomy related.The off label nature of the neck to sac angle of 77 degrees (should be less than or equal to 60 degrees) likely contributed to the migration of 14.9mm of the proximal extension and resultant type ia endoleak.The type ib endoleak was most likely due to the sac growth of the aortic aneurysm, which extended into the iliacs as it expanded.The buckling of the proximal extension was most likely due to the off label neck angulation.The final patient status was discharged on the second post operative day home in good condition following the secondary endovascular repair.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 adverse events/incidents.Device iteration is afx with duraply.Corrections: g4: date received by manufacturer- updated.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.H7: remedial action: remove data.H9: correction/removal rpt number: remove data.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented in the emergency room with back pain.A type 3a endoleak and possible type 1b endoleak were identified.The physician elected to implant a bifurcated stent graft, suprarenal aortic extension and an infrarenal aortic extension to resolve this event.The patient was reported as stable post secondary procedure.Additional information: the clinical assessment has refuted the reported type 3a endoleak, and rather confirmed a type ia and type ii (non-device-related) endoleaks.In addition, clinical identified bilateral type ib endoleaks, buckling and migration of the proximal extension, significant sac growth of 34.5mm, and an aortic rupture occurred that was not included in the event as reported.These findings were discovered during an examination of the 79-month post index ct (computed tomography) scan and angiogram.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12305316
• MDR Text Key: 265993819
• Report Number: 2031527-2021-00298
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012463
• UDI-Public: (01)00818009012463(17)170904
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Model Number: BA25-110/I20-30
• Device Lot Number: 1277662020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION, LOT # 1272455025.; SUPRARENAL AORTIC EXTENSION, LOT # 1272455025
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR