MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problems Off-Label Use (1494); Device-Device Incompatibility (2919); Separation Problem (4043)

Patient Problem Aneurysm (1708)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.

Event Description

On (b)(6) 2016, the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx limb stent graft and an afx vela suprarenal.On (b)(6) 2017, a reintervention was performed to treat a type ib endoleak in the left common iliac artery along with a coiled right internal iliac artery seen at the initial implant.The iliac anatomy and the suboptimal position of the stent in an aneurysmal vessel at the implant procedure was off-label.An ovation ix iliac limb was implanted.This procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system.This event was previously reported under mdr # 2031527-2018-00354.Reintervention was completed on an unknown date with the implant of a gore (non-endologix) stent do to the separation of the afx limb stent graft and the ovation ix iliac limb.Reported under mfr#3008011247-2023-00213.Now approximately six (6) years post initial procedure the ovation limb was found to have separated from the afx2 bifurcated stent graft resulting in a type 3a endoleak and the aneurysm is enlarging.The patient is currently being monitored while an intervention with an aorto-uni-iliac (aui) and femoral to femoral bypass is being discussed.

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 was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiia endoleak with implant separation of the left common iliac limb stent complaint is confirmed.The aneurysm enlargement complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.The complaint is most likely user related.The off-label use of an ovation ix iliac limb and non- endologix limb implanted in the left common iliac artery likely contributed to the reported event.There was also a cautionary product use condition of multiple revisions of a previously placed graft.Procedure related harms for this complaint could not be determined.The final patient status was reported as being monitored pending reintervention.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.Corrections: d4: lot expiration date - correction.D4: udi # - correction.G3: awareness date ¿ updated.H4: release date - correction.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Type of Device: 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: 18386986
• MDR Text Key: 331283226
• Report Number: 3011063223-2023-00053
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1354804013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX LIMB STENT GRAFT, LOT # 1472911006; AFX VELA SUPRARENAL, LOT # 1461844001; GORE STENT (IMPLANT DATE AND LOT UNKNOWN); OVATION IX ILIAC LIMB, LOT # FS060517-23
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male