MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I20-40
Medical Device Problem Codes	Use of Device Problem (1670); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	07/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 or Problem Description
The patient was initially implanted with a bifurcated stent graft, an suprarenal stent graft and three (3) limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, a type 3a endoleak with component separation was identified.The physician elected to reline the original implanted devices with a limb stent graft, an iliac limb extension and a palmaz stent.Reportedly, intervention was successful and the patient is doing well.
Additional 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 with complete component separation of the right common iliac artery is confirmed and the additional endovascular procedure on is confirmed.This is consistent with the reported adverse event/incident.Additionally, the clinical assessment determined that there was evidence to reasonably suggest sac growth of 15.5mm in the right common iliac artery occurred that was not included in the event as reported.The sac growth was discovered during review of the 67 month post index implant ct scan.The diameter of the right common iliac artery at index was 33mm distally (should be 10-23mm).This off label diameter likely contributed to the type iiia endoleak.The final patient status was discharged on the first post operative day following a secondary endovascular procedure.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.B5: describe event or problem - correction.G4: date of received by manufacturer - updated.H6: result code - remove code 3233.H6: conclusion code - remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, an suprarenal stent graft and three (3) limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, a type 3a endoleak with component separation was identified.The physician elected to reline the original implanted devices with a limb stent graft, an iliac limb extension and a palmaz stent.Reportedly, intervention was successful and the patient is doing well.After the initial report, clinical assessment determined that there was evidence to reasonably suggest sac growth of 15.5mm in the right common iliac artery occurred that was not included in the event as reported.The sac growth was discovered during review of the 67 month post index implant computerized tomography scan.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 12283214
• Report Number: 2031527-2021-00296
• Device Sequence Number: 3761249
• Product Code: MIH
• UDI-Device Identifier: 00818009012210
• UDI-Public: (01)00818009012210(17)180520
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2018
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1342795-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT LOT#1350054-006; AFX LIMB STENT GRAFT, LO#1350052-004; AFX LIMB STENT GRAFT, LOT#1252554-004; AFX VELA SUPRARENAL, LOT#1352104-015; AFX LIMB STENT GRAFT LOT#1350054-006; AFX LIMB STENT GRAFT, LO#1350052-004; AFX LIMB STENT GRAFT, LOT#1252554-004; AFX VELA SUPRARENAL, LOT#1352104-015
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR