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

Model Number	TV-IL1416140-J
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/19/2021
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 an alto main body and two (2) ovation ix iliac limbs.Approximately four (4) months after post initial procedure, the patient presented emergently to the hospital with abdominal pain.After an angiogram, a type 1b endoleak was identified as well as both iliac limbs had migrated back into the abdominal aneurysm.A re-intervention was done and the physician elected to implant one (1) additional ovation ix limb in each iliac.The final patient status was reported as doing fine.
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.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 bilateral limb migration, loss of seal and type 1b endoleak event(s)/incident(s) are confirmed from the still images.This is consistent with the reported adverse event/incident.Due to the absence of relevant medical records and relevant medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status remains unknown.The final patient status was not made available to endologix.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.G3: awareness date ¿ updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: 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: 12691696
• Report Number: 3008011247-2021-00126
• Device Sequence Number: 11788093
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416140J1
• UDI-Public: +M701TVIL1416140J1/$$3231109FS11062025H
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/19/2021

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: 11/09/2023
• Device Model Number: TV-IL1416140-J
• Device Catalogue Number: TV-IL1416140-J
• Device Lot Number: FS110620-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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, FS020121-14; OVATION IX ILIAC LIMB FS032421-42; OVATION PRIME FILL POLYMER FF120120-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown