MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/17/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in this event are expected to be returned for evaluation but have not yet been received.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.H3 other text : devices in transit.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately five (5) years post initial procedure, the patient presented at routine follow-up with an aneurysm enlargement and an endoleak (at indeterminate origin).Re-intervention was completed with implant of an additional afx vela suprarenal, and the endoleak was successfully sealed.The patient was reported as stable.Reference mfr.Report # 2031527-2021-00280 for this previous event.Approximately two (2) years post secondary intervention, the patient presented with unexplained aneurysm enlargement (unknown diameter).The physician elected to treat the patient by explanting the devices on (b)(6)2023, and a hygroma was diagnosed during the procedure.The patient passed away a couple of days later.
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 found one manufacturing or processing non-conformities that could contribute to the reported adverse event/incident.However, this manufacturing or processing non-conformity was identified after the implant of the complaint device.After the initiation of the manufacturing or processing non-conformity lot 1484295 underwent stent graft integrity sampling and passed.The remainder of the units from lot 1484295 were reworked (re-labeled) and released.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.Endologix performed an evaluation of the returned afx2 bifurcated stent graft and afx vela suprarenal stent graft.The devices were decontaminated.Visual inspection of the afx2 bifurcated stent graft noted that two sutures were protruding at the bifurcation of the stent, indicating the presence of holes in the graft.This type of finding is consistent with a type iiib endoleak; however, as a type iiib endoleak was not reported this device damage could have been caused during the explant procedure.Visual inspection of the afx vela suprarenal stent graft identified approximately 20mm of exposed sutures at the center of the graft and damage to the crown of the graft.This damage could have been caused during the explant procedure.The remainder of the graft integrity appeared to remain intact, with no observable defects.Based on visual inspection, a definitive root cause for the graft damage cannot be determined.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 afx2, aneurysm enlargement (of 13.6mm) and explant are confirmed.The reported death is unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported as deceased.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.A root cause investigation was carried out for the manufacturing or processing non-conformities having an identified failure mode of the larger diameter bif and limb¿s part numbers being more susceptible to graft damage.Endologix implemented the following corrective actions with the intent of reducing this type of event; 1.Revised the performance qualification (pq) test report for afx2 loading process.Device iteration is afx2.Corrections: b5 describe event or problem.D1 product family (primary).D2 common device name (primary).D4 model number (primary).D4 lot # (primary).D4 lot expiration date (primary).D4 udi # (primary).D9 date received.D10 concomitant product.G3 awareness date.H1 type of reportable event.H3 device evaluated by mfg? h3 device ret to mfg for eval? h3 reason device not evaluated; remove data.H3 reason device not eval- other; remove data.H4 release date (primary).H6 medical device problem codes; remove 3190.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately five (5) years post initial procedure, the patient presented at routine follow-up with an aneurysm enlargement and an endoleak (at indeterminate origin).Re-intervention was completed with implant of an additional afx vela suprarenal, and the endoleak was successfully sealed.The patient was reported as stable.Reference mfr.Report # 2031527-2021-00280 for this previous event.Approximately two (2) years post secondary intervention, the patient presented with unexplained aneurysm enlargement (unknown diameter).The physician elected to treat the patient by explanting the devices on (b)(6) 2023, and a hygroma was diagnosed during the procedure.The patient passed away a couple of days later.Additional information: sample evaluation of the returned explanted devices identified presence of holes in the afx2 bifurcated stent graft.

• 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: 17144834
• Report Number: 2031527-2023-00170
• Device Sequence Number: 5578014
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)170525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 05/24/2023

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: 05/25/2017
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 1484295-018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2016
• 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, SN (B)(6); AFX VELA SUPRARENAL, SN (B)(6); AFX VELA SUPRARENAL, SN (B)(6); AFX2 BIFURCATED STENT GRAFT, SN (B)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Female