MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number I20-20/C55F SA

Device Problem Material Puncture/Hole (1504)

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.

• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Date Manufacturer Received: 03/05/2024
• 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): Other
• Patient Age: 84 YR
• Patient Sex: Male