MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BA22-60/116-40

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 12/18/2020

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 afx2.

Event Description

The patient was initially implanted with a afx2 bifurcated stent graft, a vela suprarenal and a vela infarenal endograft to treat a abdominal aortic aneurysm (aaa).It was reported that the patient failed to return for future routine follow up appointments after the 1 year follow up.Approximately (4) four years post initial procedure the patient was transported to the hospital for abdominal pain and a rupture of the aaa was confirmed.The patient had been transferred to a different hospital for treatment and had went into cardiac arrest.Per patient¿s family request no additional treatment were performed and the patient expired on 21dec2020.Another ct (computed tomography) revealed type 3a endoleak with separation resulting in the rupture of the aneurysm.

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 and rupture were confirmed.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.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 afx2.Corrections: g1 and g2: contact office.G4: awareness date.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

Event Description

The patient was initially implanted with a afx2 bifurcated stent graft, a vela suprarenal and a vela infarenal endograft to treat a abdominal aortic aneurysm (aaa).Approximately (4) four years post initial procedure, a type 3a endoleak with device separation causing a rupture aaa was identified.The patient was being transferred to a different hospital for treatment however went into cardiac arrest.Per patient¿s family request no additional treatment was performed and the patient expired on (b)(6) 2020.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11228196
• MDR Text Key: 241236364
• Report Number: 2031527-2021-00026
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010193
• UDI-Public: (01)00818009010193(17)190624
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: 06/24/2019
• Device Model Number: BA22-60/116-40
• Device Lot Number: 1411854001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA INFRARENAL - 1568574016; AFX VELA SUPRARENAL - 1453284021
• Patient Outcome(s): Death
• Patient Age: 75 YR