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

Model Number	TV-IL1418160-J
Medical Device Problem Codes	Material Invagination (1336); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Clinical Endoleak (4843)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.Approximately two (2) days post initial procedure, the patient returned with right leg pain.The ct (computed tomography) scan noted that the right iliac limb was kinked and had thrombus within graft.The physician elected to treat the patient with thrombectomy and implanted an ovation ix iliac limb.Patient is reportedly stable, and thrombus was successfully resolved.
Additional 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 because 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 right common iliac artery occlusion (with thrombus) with additional surgical procedure (right groin cutdown/ thrombectomy) complaints are confirmed.The buckled implant complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest type ii endoleak (of accessory renal artery) with additional endovascular procedure (coils) during index procedure occurred that was not included in the event as reported.The type ii endoleak was discovered during an examination of during review the operative note dated 03/08/2024.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The thrombus in the right common iliac artery stent created right iliac limb occlusion.It is unclear why the thrombus occurred.Type ii endoleak is anatomy related.The final patient status was reported as discharged to home on postoperative day five.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- medical device problem codes remove 1336.H6- investigation finding codes: removed 3233.H6- investigation conclusion codes: removed 11.

• Brand Name: OVATION IX
• Common Device Name: 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: 18952431
• Report Number: 3008011247-2024-00025
• Device Sequence Number: 7085118
• Product Code: MIH
• UDI-Device Identifier: 00850007370374
• UDI-Public: (01)00850007370374(17)261108(10)FS110723-14
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: TV-IL1418160-J
• Device Lot Number: FS110723-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTO MAIN BODY, LOT # FS080923-70; OVATION IX ILIAC LIMB, LOT # FS050223-07; OVATION PRIME FILL POLYMER, LOT # FF103023-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male