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

Model Number	TV-IL1412120-E
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Rupture (2208); Clinical Endoleak (4843)
Date of Event	03/01/2023
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 the implant of the ovation prime abdominal aortic aneurysm stent system.Approximately seven (7) years after the post initial procedure, the patient presented with a ruptured aneurysm originating from the iliac artery.One of the iliac limbs had retracted back into the sac while the other had minimal purchase in the iliac.The patient underwent a re-intervention where two (2) ovation ix iliac limbs were implanted.The patient's current condition is stable in the post-event phase.
Additional Manufacturer Narrative
The reported 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 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 event/incident.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 rupture of the aaa and additional endovascular procedures are confirmed.This is consistent with the reported event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 1b endoleak and sac growth of 9mm also occurred.The endoleak and aaa sac growth was discovered during a review of the discharge summary.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was discharged on postoperative day one in improved condition.No additional investigation of this reported 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 events/incidents.Corrections: b5: describe event or problem has been updated.G3: date received by manufacturer has been updated.H6: investigation finding: remove code 3233.H6: investigation conclusion: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of the ovation prime abdominal aortic aneurysm stent system.Approximately seven (7) years after the post initial procedure, the patient presented with a ruptured aneurysm originating from the iliac artery.One of the iliac limbs had retracted back into the sac while the other had minimal purchase in the iliac.The patient underwent a re-intervention where two (2) ovation ix iliac limbs were implanted.The patient's current condition is stable in the post-event phase.Additional information: a clinical evaluation showed reasonable evidence to suggest a type 1b endoleak and sac growth of 9mm also occurred.The endoleak and aaa sac growth was discovered during a review of the discharge summary.

• Brand Name: OVATION PRIME
• 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: 16566334
• Report Number: 3008011247-2023-00034
• Device Sequence Number: 5895602
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412120E1
• UDI-Public: +M701TVIL1412120E1/$$3180115FS10081425A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 02/28/2023

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: 01/15/2018
• Device Model Number: TV-IL1412120-E
• Device Catalogue Number: TV-IL1412120-E
• Device Lot Number: FS100814-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/30/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• 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: OVATION PRIME FILL POLYMER FF021915-02; OVATION PRIME ILIAC LIMB FS012313-10; OVATION PRIME ILIAC LIMB FS082014-30; OVATION PRIME ILIAC LIMB FS102014-35; OVATION PRIME MAIN BODY FS061714-70
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male