MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number A34-34/C100V

Device Problems Off-Label Use (1494); Migration (4003); Lack of Effect (4065)

Patient Problem Aneurysm (1708)

Event Date 03/07/2024

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 afx (duraply).

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft, afx vela infrarenal, and an ovation ix iliac limb on (b)(6) 2017.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx system per the instructions for use (ifu).Approximately 3.5 years post-initial procedure, during a routine follow-up (cta) computed tomography angiography, the patient was identified with a type 1a endoleak.Reintervention was not reported to endologix (previously reported under mfr#2031527-2021-00233).During a routine follow-up on (b)(6) 2024, a type 1a endoleak was identified due to the proximal extension falling out of the neck.On (b)(6) 2024, the patient underwent a re-intervention where the physician implanted two (2) afx vela infrarenals, two (2) afx vela suprarenals, and an ovation ix extender.The final patient status remains unknown.The final patient status was not made available to endologix.

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 was 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the afx, endoleak type 1a, and additional endovascular procedures are confirmed.The complaint is most likely anatomy-related.This is consistent with the reported adverse event/incident.The initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices (ovation limb) not compatible with the afx system per the instructions for use (ifu).It is unlikely this contributed to the reported event.The clinical evaluation also shows reasonable evidence to suggest infrarenal cuff migration of 36.9 mm and aneurysm enlargement of 16.6 mm occurred.This was discovered during a review of the computed tomography (ct) scan.There was a sharp juxtarenal angulation of 88.4° that likely contributed to the cuff migration (anatomy-related).The cuff migration likely contributed to the type ia endoleak.No procedure-related harms were identified.The final patient status was reported as discharged home on postoperative day one (1).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 afx (duraply).Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.H6: medical device probem codes - remove code 4065.

• Brand Name: AFX
• Type of Device: VELA INFRARENAL
• 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: 18986336
• MDR Text Key: 338704371
• Report Number: 3011063223-2024-00046
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)200801
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 08/01/2020
• Device Model Number: A34-34/C100V
• Device Lot Number: 1725965-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT 1680806002; OVATION IX ILIAC LIMB FS103017-50
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male