MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 or Problem Description
The patient was initially implanted with an afx2, bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).On (b)(6) 2020, a secondary procedure was preformed for an unknown reason.Two (2) ovation ix, limb stent graft extenders and a non - endologix (gore vbx) stent were implanted.This case is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.Now, approximately three (3) years post initial procedure, a type 3b and type 2 endoleaks were reported.A third procedure was completed.The physician elected to reline the originally implanted devices with another afx2, bifurcated stent graft to resolve this event.The patient was reported as doing well and had been discharged.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately six years of post-deployment, md lumbar spine with obliques was performed due to low back pain and result showed that there was an inferior vena cava filter noted with a fracture strut fragment identified in close approximation.After, twelve days, the patient presented for hospital visit and had a recent evaluation for back pain and was noted to have a strut fracture on inferior vena cava filter.Around, three years and eight months later, computed tomography of abdomen with contrast was performed due to abdominal pain and result showed that there was presence of an inferior vena cava filter in with slight posterior tilt situated below the renal veins with the distal tines of the filter projected beyond the lumen of the inferior vena cava without evidence of fracture with one of the posterior tines slightly eroded into the right anterior superior endplate of l4.Around, three months and three weeks later, computed tomography of abdomen and pelvis with and without intravenous contrast showed that the inferior vena cava filter with struts extended beyond the wall of the inferior vena cava.Therefore, the investigation is confirmed for filter limb detachment and perforation of the inferior vena cava (ivc).Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: (expiration date: 03/2012); (manufacturing date: 03/2009).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 12749126
• Report Number: 2031527-2021-00459
• Device Sequence Number: 4480528
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)190110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 01/10/2019
• Device Model Number: BEA25-70/I20-30
• Device Lot Number: 1775300-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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: GORE VBX STENT (NON- ENDOLOGIX); OVATION IX, LIMB EXTENDER, LOT FS031120-01; OVATION IX, LIMB EXTENDER, LOT FS042920-37
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male