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

Model Number	TV-IL1422120-E
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/25/2019
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.Other text : devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation prime abdominal aortic aneurysm stent system.Approximately three and a half (3.5) years post initial procedure, the patient presented with a type ib endoeak.The physician elected to treat the patient by implanting one (1) ovation ix extender on (b)(6).The final patient status post secondary intervention is unknown.
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 ovation prime, type ib endoleak (of the right common iliac artery) is unconfirmed.The reported additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (site unknown) occurred that was not in the event as reported.This finding was discovered during an examination of discharge summary dated 16 october 2022.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.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 codes; remove 3233.H6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation prime abdominal aortic aneurysm stent system.Approximately three and a half (3.5) years post initial procedure, the patient presented with a type ib endoeak.The physician elected to treat the patient by implanting one (1) ovation ix extender on (b)(6) 2019.The final patient status post secondary intervention is unknown.Additional information: clinical assessment identified that a non-device-related type ii endoleak was also present.

• 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: 16665100
• Report Number: 3008011247-2023-00043
• Device Sequence Number: 12413995
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120E1
• UDI-Public: +M701TVIL1422120E1/$$3171218FS10081419I
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/25/2019

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: 12/18/2017
• Device Model Number: TV-IL1422120-E
• Device Catalogue Number: TV-IL14122120-E
• Device Lot Number: FS100814-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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, LN FF031815-01; OVATION PRIME ILIAC LIMB, LN FS082614-06; OVATION PRIME MAIN BODY, LN FS082514-60
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male