MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number A28-28/C95

Device Problems Collapse (1099); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/17/2018

Event Type  Injury  

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 Description

The patient was initially implanted with an afx bifurcated stent graft and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 2 1/2 years later, a computed tomography (ct) scan identified a type 1a endoleak.The physician elected to treat this event with a non-endologix device (endurant aortic proximal extension).

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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.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 ia endoleak event is confirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review and the absence of the pre index procedure medical imaging.The clinical evaluation also shows reasonable evidence to suggest buckling of the proximal extension occurred.These findings were discovered during an examination of the post computed tomography scan (ct) dated (b)(6) 2018.The final patient status remains unknown.The final patient status was not made available to endologix.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: b5: describe event or problem has been updated.D2: product description has been updated d4: model number has been updated.D4: lot # has been updated.D4: expiration date has been updated.D4: unique identifier (udi) # has been updated.D11: concomitant medical products and therapy dates has been updated.G4: date of received by manufacturer has been updated.H4: device manufacture date has been updated.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 an afx bifurcated stent graft and a vela infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 2 1/2 years later, a computed tomography (ct) scan identified a type 1a endoleak.The physician elected to treat this event with a non-endologix device (endurant aortic proximal extension).Correction: the patient was initially implanted with an afx bifurcated stent graft and an infrarenal aortic stent graft extension to treat an abdominal aortic aneurysm (aaa).Additional information: clinical assessment identified buckling of the proximal extension.

• Brand Name: AFX
• Type of Device: INFRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10544241
• MDR Text Key: 207309194
• Report Number: 2031527-2020-00265
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)190107
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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: 09/23/2018
• Device Model Number: A28-28/C95
• Device Lot Number: 1379614014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT, LOT# 1283301005.; INFRARENAL EXTENSION, LOT NO. 1379614014.
• Patient Outcome(s): Required Intervention