MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I20-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2019.The left internal iliac artery (iia) and inferior mesenteric artery were occluded and then a non-endologix gore excluder leg (16/12-10) was implanted in the left side.An afx2 bifurcated stent graft and an afx vela suprarenal were then implanted.The procedure was completed with no endoleak.This initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.On (b)(6) 2023, reintervention was performed to treat aneurysm enlargement and an indeterminate endoleak (possible type ia, iiia or ib).The right iia was occluded, and a non-endologix boston scientific was deployed in the superior mesenteric artery due to a dissection from an unknown cause.An afx vela suprarenal was deployed just below the renal artery and an afx limb extension was deployed on the right side.Balloon touch-up was performed and there was no apparent endoleak.The reintervention was completed.Patient status was not provided.(reported under mfr#: 3011063223-2023-00020).A follow-up performed on (b)(6) 2023, identified that aneurysm had occurred again.The tertiary was performed on (b)(6) 2023.During the open surgery a hole was confirmed on afx2 bifurcated stent graft (type iiib endoleak) just below the proximal edge, blood was jetting.During the explanation the afx2 bifurcated stent graft was cut into several pieces.The two afx vela that were explanted are available for investigation.An i-graft replacement was performed, and the operation was completed.Patient status post explant was reported to be stable.
Additional Manufacturer Narrative
The afx2 bifurcated stent graft will not be returned for evaluation as during the explanation the afx2 bifurcated stent graft was cut into several pieces.The two afx vela that were explanted are expected to be returned for evaluation; however, they 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 afx2.H3: other text: device discarded by the hospital.
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 performed an evaluation of the one returned explanted afx vela suprarenal stent graft.The device was received in a biohazard containment bag.The device was decontaminated due to the presence of blood and tissue residue.A visual analysis found no found no significant damage.The afx2 bifurcated stent (complaint device) was not returned for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement and the open conversion and explant complaints are confirmed.The type iiib endoleak is unconfirmed.This is moderately consistent with the reported adverse event/incident.There was no type iiib endoleak seen on the computed tomography scan before the secondary procedure which was done (b)(6) 2023.It could not be conclusively determined that the high velocity pin hole observed during the surgical conversion was a type iiib endoleak that developed since (b)(6) 2023 or surgical conversion damage.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Additional Manufacturer Narrative
Correction: d6: explant date.

• 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: 18014358
• Report Number: 3011063223-2023-00021
• Device Sequence Number: 20717275
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)200126
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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: 01/26/2020
• Device Model Number: BEA25-70/I20-30
• Device Lot Number: 1780629003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/13/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/21/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• 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 LIMB EXTENSION (SN (B)(6)).; AFX VELA INFRARENAL (SN (B)(6)).; AFX VELA SUPRARENAL (SN (B)(6)).; BOSTON SCIENTIFIC (NON-ENDOLOGIX).; GORE EXCLUDER (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male