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

Model Number	TV-IL1410140-J
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an alto stent graft system.Approximately two (2) months post initial procedure a small type 3b endoleak was identified.The patient will undergo a re-intervention, the date to be determined.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an alto stent graft system.Approximately two (2) months post initial procedure a small type 3b endoleak was identified.The patient will undergo a re-intervention, the date to be determined.Additional information received indicated that the patient did not have an aaa present at time of initial implant (off-label condition) and that the alto system was implanted as treatment of the patient's occlusive disease.The physician has elected to continue monitoring the patient as there is no sac growth.
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 the reported type 3b endoleak (of the iliac limb) is unconfirmed.This is not consistent with the reported adverse event/incident.The device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.No procedure-related harms were identified.Potential contributing factors to the event include the following: non-endologix stents previously implanted in the iliacs (off-label concomitant product use), patient had aortoiliac occlusive disease (off-label) and extensive calcifications noted throughout the aorta and iliacs (cautionary product use).The final patient status was discharged home on the first postoperative day in stable condition.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 codes; remove 3233.H6 investigation conclusion codes; remove 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: 15254550
• Report Number: 3008011247-2022-00097
• Device Sequence Number: 6710811
• Product Code: MIH
• UDI-Device Identifier: 00850007370145
• UDI-Public: (01)00850007370145(17)250207(10)FS020422-03
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/27/2022

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: 02/07/2025
• Device Model Number: TV-IL1410140-J
• Device Lot Number: FS020422-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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 FS041322-36; OVATION IX ILIAC LIMB FS033022-60; OVATION PRIME FILL POLYMER FF081321-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female