MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation of Vessels (2135); Clinical Endoleak (4843)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft.Approximately seven and a half (7.5) years post initial procedure, the patient presented with a type ia endoleak.The physician elected to treat the patient by implanting a medtronic (non-endologix) 30mm proximal cuff on (b)(6) 2022.During this secondary procedure, the iliac artery ruptured.The physician then successfully implanted three (3) ovation ix iliac limbs.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft.Approximately seven and a half (7.5) years post initial procedure, the patient presented with a type ia endoleak.The physician elected to treat the patient by implanting a medtronic (non-endologix) 30mm proximal cuff on (b)(6) 2022.During this secondary procedure, the iliac artery ruptured.The physician then successfully implanted three (3) ovation ix iliac limbs.Additional information: clinical assessment indicated that a type iiia endoleak (of the aortic components) also occurred at time of event.Also, a non-endologix proximal extension was identified as implanted during the index procedure on (b)(6) 2015 (off-label use).
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.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 reported afx type ia endoleak is unconfirmed.The reported right iliac artery rupture and additional endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type iiia endoleak (of the aortic components) occurred that was not included in the event as reported.This finding was discovered during an examination of the ct (computed tomography) scan dated 05 august 2022 and operative report dated 21 november 2022.The most likely causation for the reported event is user-related due to the concomitant product use of a non-endologix thoracic extension and aptus endo anchors proximally; this off-label condition likely contributed to the type iiia endoleak.Procedure-related harms include abnormal (1000ml) blood loss (patient given 1 unit prbc (packed red blood cells)), and an access-site complication of the left common femoral artery occlusion requiring an additional surgical procedure (femoral endarterectomy with patch and embolectomy).The final patient status was reported as discharged to rehabilitation on postoperative day nine.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.G3 awareness date.H6 health effect - clinical code; remove 1924.H6 medical device problem codes; remove 3191.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.H7 if remedial action init.H9 correction/removal rpt num.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 15988760
• Report Number: 2031527-2022-00280
• Device Sequence Number: 5961886
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)171107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 11/07/2017
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265981-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: NON-ENDOLOGIX PROXIMAL EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female