MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number TV-IL1428140-J

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 due to the separation of the afx limb stent graft and the ovation ix iliac limb.

Manufacturer Narrative

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

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 implant separation (afx stent graft and the lcia ovation ix iliac limb) and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure and anatomy relatedness of this complaint is undetermined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: OVATION IX
• Type of Device: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 18387029
• MDR Text Key: 331283303
• Report Number: 3008011247-2023-00213
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428140J1
• UDI-Public: +M701TVIL1428140J1/$$3200607FS06051723Q
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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: 06/30/2020
• Device Model Number: TV-IL1428140-J
• Device Lot Number: FS060517-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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: AFX LIMB STENT GRAFT (LN 1472911006); AFX VELA SUPRARENAL (LN 1461844001); AFX2 BIFURCATED STENT GRAFT (LN 1354804013)
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male