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

Model Number	TV-IL1414140-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 implanted with the ovation prime abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately (6) six years after the post-initial procedure, a type 2 endoleak and a type 1b endoleak was identified.The physician is planning to re-intervene, but surgery has not been scheduled.The patients current condition 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 that the type 1b endoleak of the right common iliac artery, type 2 endoleak (non device related) of the internal mesenteric artery and the secondary endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.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 the same day home after the procedure.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G4: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with the ovation prime abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately (6) six years after the post-initial procedure, a type 2 endoleak and a type 1b endoleak was identified.The physician is planning to re-intervene, but surgery has not been scheduled.The patients current condition is unknown.Additional information: the type 1b endoleak was found during routine follow up.The physician elected to implant an ovation ix iliac limb and an ovation ix extender to successfully resolve the event.The patient was reported as discharged post secondary procedure.

• Brand Name: OVATION PRIME
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12350573
• Report Number: 3008011247-2021-00092
• Device Sequence Number: 5292061
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414140E1
• UDI-Public: +M701TVIL1414140E1/$$3180129FS01241559P
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 01/29/2018
• Device Model Number: TV-IL1414140-E
• Device Catalogue Number: TV-IL1414140-E
• Device Lot Number: FS012415-59
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION PRIME, FILL POLYMER, LOT#FF103114-02.; OVATION PRIME, ILIAC LIMB, LOT#FS080514-55.; OVATION PRIME, MAIN BODY, LOT#FS110713-29.; OVATION PRIME, FILL POLYMER, LOT#FF103114-02; OVATION PRIME, ILIAC LIMB, LOT#FS080514-55; OVATION PRIME, MAIN BODY, LOT#FS110713-29
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR