MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
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 type ib endoleak (of the right common iliac artery) and aortic rupture are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to off-label right iliac artery; aneurysm extended into the bilateral iliacs and there was inadequate distal fixation length.Concomitant product use of a non-endologix left renal artery stent was also noted, but this did not likely contribute to the event.It was also noted that the type ib endoleak was visible per the 1-month post ct scan (dated two months prior to the rupture); the delay in treatment likely contributed to the rupture (user error).Procedure-related harms identified were acute renal failure and a prolonged hospitalization.The final patient status was reported as discharged to a skilled nursing facility on the seventh post operative day.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.H3 other text : devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft, an afx vela suprarenal proximal extension and three (3) afx limb stent graft distal extensions.Approximately three (3) months post initial implant procedure, the patient presented emergently with a ruptured aaa and ct (computed tomography) detected a type ib endoleak from the right common iliac.The physician elected to treat the patient by implanting an additional afx limb stent graft with two (2) ovation ix extenders on (b)(6) 2020.The patient was reportedly in stable condition post re-intervention.Subsequent to the initial report, clinical assessment determined that the initial procedure was off-label due to the right iliac artery: the aneurysm extended into bilateral iliacs and there was not an adequate distal fixation length, as 15mm above the right internal iliac artery the vessel was aneurysmal at 23.8mm (ifu requirement is 10-23mm).Reference mfr.Report # 3008011247-2020-00046 for initial report to this event (patient id (b)(6) submitted on 23 march 2020.As the cfn/fei # was incorrect on report 3008011247-2020-00046 due to an afx primary product, this initial/final report is being submitted for correction.

• Brand Name: AFX
• Common Device Name: LIMB 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: 17563866
• Report Number: 2031527-2023-00207
• Device Sequence Number: 20504140
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)211207
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 2018113-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT, SN (B)(6); AFX LIMB STENT GRAFT, SN (B)(6); AFX VELA SUPRARENAL, SN (B)(6); AFX2 BIFURCATED STENT GRAFT, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male