MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation, but still pending evaluation.As soon as the investigation is completed a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and a medtronic endurant leg stent (non-endologix) to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Approximately 3 months post initial procedure, a type ii endoleak (non- device related failiure) was identified with no re-intervention.Now, reportedly, 6 months post initial procedure the patient presented with a ruptured aneurysm due to a type iiib endoleak.The physician elected perform an open repair with explant the devices and treated the patient with a y-graft (non-endologix).The re-intervention was successfully completed.
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.Endologix received a one (1) afx bifurcated stent graft and one (1) afx vela suprarenal stent graft for evaluation.The devices were shipped in a biohazard returned bag within a one (1) box.Blood and tissue residue were present upon receipt.The devices were decontaminated.A visual analysis was performed.The afx bifurcated stent graft had three (3) small holes identified in the graft material.Two (2) holes were at the proximal end of the graft and one (1) hole was located near the bifurcation of the stent.The integrity of the graft appears to be intact with no visible defects for the afx vela suprarenal stent graft.The reported type 3b endoleak was confirmed as there were holes identified within the graft of the afx bifurcated stent.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirmed the reported 3b endoleak of the bifurcated stent graft, type 2 endoleak of the internal mesenteric artery, ruptured aorta and device explant.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.However, during the investigation, endologix found reasonable evidence to suggest the device was used off-label.There was concomitant product use of a non endologix stent in the right common iliac artery and thickened calcifications at times almost circumferential at the bifurcation.The luminal diameter of the bifurcation at this point was 12.8 x 11mm.Without additional medical records / images, it is unclear if these contributed to the reported event.The final patient status was not reported post open repair procedure.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.

• Brand Name: AFX2
• 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: 14473997
• Report Number: 2031527-2022-00104
• Device Sequence Number: 14655029
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)221114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2022

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: 11/14/2022
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 23086830-004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX, VELA SUPRARENAL, LOT#2436193-003; MEDTRONIC (NON-ENDOLOGIX) ENDURANT LEG (10-93)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male