MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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 or Problem Description
A bifurcated stent graft and a suprarenal extension was implanted to treat an abdominal aortic aneurysm.Reportedly, an intraoperative type 3b endoleak remained and the physician elected to monitor the patient and follow up in 30 days with a computed tomography scan.Patient is doing well, asymptomatic and discharged on the next day.
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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported iiib endoleak of the main body is refuted, rather a small type ii endoleak (of the lumbar artery) was confirmed.This is not consistent with the reported adverse event/incident.The most likely causation for the reported event is anatomy-related.Procedure-related harms could not be determined with the medical records available for review.The final patient status was reported as being stable.Corrections: b5 describe event or problem.G4 awareness date.H6 remove all codes.
Event or Problem Description
A bifurcated stent graft and a suprarenal extension was implanted to treat an abdominal aortic aneurysm.Reportedly, an intraoperative type 3b endoleak remained and the physician elected to monitor the patient and follow up in 30 days with a computed tomography scan.Patient is doing well, asymptomatic and discharged on the next day.Additional information received per clinical assessment refuting the type iiib endoleak, and instead confirming a type ii endoleak (non-device-related).Therefore, this event is no longer reportable as there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11704247
• Report Number: 2031527-2021-00168
• Device Sequence Number: 17055365
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 05/15/2022
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 2247809003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: VELA SUPRARENAL, LOT#2265427013.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR