MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number I20-20/C55F SA

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Event Date 03/05/2024

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 with duraply h3 other text : device remains implanted.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft, a suprarenal aortic extension, two (2) iliac limbs and an ovation extension 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 six and a half (6.5) years post initial procedure, the patient was found to have a type 3b endoleak from one of the iliac limbs.The patient is currently being monitored while an intervention 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 3b endoleak of the distal main body and the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation shows that the angiogram dated 03/08/2024 shows a the original grafts were relined with a non-endologix main body and limbs and the endoleak was resolved.The clinical evaluation also shows reasonable evidence to suggest the initial procedure is off label due to concomitant product usage (ovation limb) not compatible with the afx system per device ifu.This did not appear to contribute to the reported event.The most likely causation for this event is anatomy related due no abdominal aortic aneurysm present (off label).The right common iliac artery diameter was =40mm (should be 10-23mm) (off label).There were thickened calcifications in the area of the type 3b endoleak which is anatomy related.No procedure related harms for this complaint could be identified.The final patient status was reported as discharged home on postoperative day one.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 with duraply corrections: b2: outcomes attributed to adverse events has been updated b5: describe event or problem has been updated g3: awareness date has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: remove code 11.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft, a suprarenal aortic extension, two (2) iliac limbs and an ovation extension 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 six and a half (6.5) years post initial procedure, the patient was found to have a type 3b endoleak from one of the iliac limbs.The patient is currently being monitored while an intervention is being discussed.Additional information: the clinical evaluation shows that the angiogram dated 03/08/2024 shows a the original grafts were relined with a non-endologix main body and limbs and the endoleak was resolved.

• Brand Name: AFX
• Type of Device: LIMB 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: 18968783
• MDR Text Key: 338491791
• Report Number: 3011063223-2024-00044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009011435
• UDI-Public: (01)00818009011435(17)181014
• 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: 03/05/2024

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: 10/14/2018
• Device Model Number: I20-20/C55F SA
• Device Lot Number: 1252571003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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-0009-2019
• Patient Sequence Number: 1
• Treatment: AFX LIMB STENT GRAFT, LOT # 1361095012; AFX VELA SUPRARENAL, LOT # 1619303004; AFX2 BIFURCATED STENT GRAFT, LOT # 1623558R005; OVATION IX EXTENDER, LOT # FS032117-15
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male