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

Model Number	TV-IL1418140-J
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/06/2023
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).During this initial procedure, the inferior mesenteric artery (ima was intentionally occluded.After implant of the alto main body there was no type 1a endoleak noted.The contralateral limb was implanted on the right side.During insertion of the ipsilateral iliac limb on the left side, the alto main body moved slightly; however, the physician continued the implant of the limb followed by an iliac extension on the right side.An indeterminate endoleak was observed and the physician decided to monitor the patient not to perform any further treatment at that time.Reference mfr # 3008011247-2023-00198 for this event.Approximately three or four days post initial procedure a contrast computed tomography (ct) was taken prior to patient discharge and showed left limb stenosis around the terminal aorta.An emergency intervention was performed at that time and a bare stent was implanted on the left limb.It was reported that the six (6) month follow-up contrast ct showed a possible type 1a endoleak.The patient was admitted to the hospital on (b)(6) 2023 for additional evaluation and the endoleak was confirmed again.The physician decided to monitor the patient without additional procedure at this point.Reference mfr # 3008011247-2023-00200 for this event.
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 limb stenosis on the left and intervention completed with a bare metal stent (bms is unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Final patient status was reported as being monitored.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.H3 other text : device remains implanted.

• 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: 18312848
• Report Number: 3008011247-2023-00199
• Device Sequence Number: 12418688
• Product Code: MIH
• UDI-Device Identifier: 00850007370305
• UDI-Public: (01)00850007370305(17)250523(10)FS052022-47
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2025
• Device Model Number: TV-IL1418140-J
• Device Lot Number: FS052022-47
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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 # FS080422-16; OVATION IX ILIAC LIMB, LOT # FS032522-11; OVATION IX ILIAC LIMB, LOT # FS090622-19; OVATION PRIME FILL POLYMER, LOT # FF081822-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male