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

Model Number	TV-IL1410120-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Failure of Implant (1924); Thrombosis/Thrombus (4440)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately three (3) weeks post initial procedure, a follow up computed tomography angiogram (cta) showed that the patient¿s right limb has thrombosed.It was reported that there is a possibility that the limb thrombosis could be from the perclose (non-endologix) device; however, that could not be determined without evaluating the ct.It was also reported that there was severe common femoral artery stenosis which may be the cause of the event.The patient was symptomatic and was referred to another facility where a fem-fem bypass procedure was performed to resolve this event.
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.Device remains implanted.
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.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 right iliac limb thrombosis causing a right limb occlusion with additional surgical intervention (femoral to femoral bypass) events are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this event could not be determined.The procedure related harm identified was bilateral groin hematomas.It was reported that there was severe calcification of the right femoral artery with tortuous bilateral iliac arteries.This likely contributed to the reported events but could not be conclusively 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: h6: investigation finding: remove code 3233 h6: investigation conclusion: remove code 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: 15670836
• Report Number: 3008011247-2022-00133
• Device Sequence Number: 6496728
• Product Code: MIH
• UDI-Device Identifier: 00850007370138
• UDI-Public: (01)00850007370138(17)250331(10)FS033122-01
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/11/2022

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: 03/31/2025
• Device Model Number: TV-IL1410120-J
• Device Lot Number: FS033122-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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 # FS060722-23; OVATION IX ILIAC LIMB, LOT # FS032322-39; OVATION IX ILIAC LIMB, LOT # FS061622-40; OVATION PRIME FILL POLYMER, LOT # FF030922-02
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown