MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT DELIVERY SYSTEM

Model Number	BA25-80/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional 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.Device not returned as of yet.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).It was reported that during the initial procedure, after the successful release of the bifurcated body and lateral (right) limb, the sure-pass wire did not release the contralateral limb.After excessive force from the physician, the limb opened but the sure-pass wire did not pass through the introducer, tearing the artery.An intervention was performed with a positron emission tomography (pet) (bovine pericardium graft).The artery repair was successful, and the procedure was completed successfully.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.Endologix received one (1) sure pass wire and one (1) control cord were returned.The devices were shipped in a box and double bagged.The assembly was returned bent into a circle tangled together.Blood and tissue residue were present upon receipt.The devices were decontaminated.A visual analysis was performed.The sure pass wire and control cord were used with no evidence of any damage.Due to the delivery system not being returned, endologix could not duplicated the reported event.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix was unable to confirm the reported difficulty to deploy the contralateral limb, sure pass wire issues and arterial injury.This is not 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.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.Corrections: h3: device evaluated by manufacturer has been updated, h6: method code: remove code 4117, h6: result code: remove code 3233, h6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT DELIVERY SYSTEM
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11405631
• Report Number: 2031527-2021-00066
• Device Sequence Number: 19902295
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)211113
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 11/13/2021
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 2010171004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other