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

Model Number	TV-IL1416100-J
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/28/2023
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 implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure, during a routine follow up, a junction endoleak (categorized as a type 3a endoleak) was identified.The physician elected to implant an ovation ix iliac limb stent graft to successfully resolve this event.The patient status was reported as stable.This event was previously reported under mdr # 3008011247-2021-00140.On 28 august 2023, during routine follow up, another junctional endoleak was suspected at the proximal part of the limb.The patient was brought back on (b)(6) 2023 and an angiogram was performed.An endoleak was difficult to visualize; however, the physician determined this to be a type 3a endoleak and elected to treat the patient by placing 14x45 ovation limbs to each of the gates raising the bifurcation.The patient was reported as doing fine post this tertiary procedure.
Event or Problem Description
The patient was initially implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure, during a routine follow up, a junction endoleak (categorized as a type 3a endoleak) was identified.The physician elected to implant an ovation ix iliac limb stent graft to successfully resolve this event.The patient status was reported as stable.This event was previously reported under mdr # 3008011247-2021-00140.On (b)(6) 2023, during routine follow up, another junctional endoleak was suspected at the proximal part of the limb.The patient was brought back on (b)(6) 2023 and an angiogram was performed.An endoleak was difficult to visualize; however, the physician determined this to be a type 3a endoleak and elected to treat the patient by placing 14x45 ovation limbs to each of the gates raising the bifurcation.The patient was reported as doing fine post this tertiary procedure.Additional information: an internal clinical assessment refuted the type 3a endoleak, rather it was determined to be a type 2 endoleak (non-device related).Type 2 endoleaks are anatomy related events and are not caused or contributed by the device.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.
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 3a endoleak is refuted, rather it was determined to be a type 2 endoleak (non-device related).The additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The type 2 endoleak of the lumbar arteries is anatomy related.No procedure related harms for this complaint were identified.The final patient status was reported as discharged home on postoperative day one.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.Please remove from your complaint system as there was no device failure this is no longer considered a complaint.Corrections: b5: describe event or problem has been updated.G3: awareness date has been updated.H6: medical device problem codes: remove code 4065.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: 17749389
• Report Number: 3008011247-2023-00164
• Device Sequence Number: 20142519
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416100J1
• UDI-Public: +M701TVIL1416100J1/$$3230814FS08132024I
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/28/2023

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: 08/14/2023
• Device Model Number: TV-IL1416100-J
• Device Lot Number: FS081320-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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: OVATION IX ILIAC LIMB, LOT # FS013020-08; OVATION IX ILIAC LIMB, LOT # FS051921-27; OVATION IX MAIN BODY, LOT # FS021220-30; OVATION PRIME FILL POLYMER, LOT # FF060320-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown