MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION PRIME; MAIN BODY

Model Number	TV-AB2980-E
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ovation prime stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately eight and half (8.5) years post initial procedure, the aaa was found to have still been growing.Only computed tomography (ct) scans were performed to detect the aneurysm growth and no angiogram was done; however, the physician elected to explant the stent grafts in (b)(6) 2024 (exact date is unknown).The graft was fully intact when explanted but it was covered in bile and pus.The proximal fixation stent of the ovation prime was not explanted and remained in the patient.The explanted stent grafts were not returned and the final patient status at the time was not reported to endologix.
Additional Manufacturer Narrative
The device involved in this event was partially explanted and the explanted portion was not returned for evaluation as it was discarded.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 implanted with the ovation prime stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately eight and half (8.5) years post initial procedure, the aaa was found to have still been growing.Only computed tomography (ct) scans were performed to detect the aneurysm growth and no angiogram was done; however, the physician elected to explant the stent grafts on (b)(6) 2024.The graft was fully intact when explanted but it was covered in bile and pus.The proximal fixation stent of the ovation prime was not explanted and remained in the patient.The explanted stent grafts were not returned and the final patient status at the time was not reported to endologix.
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 explanted but it was not returned to endologix for evaluation.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 aneurysm enlargement of 10.2 mm and surgical conversion with explant are confirmed.This is consistent with the reported adverse event/incident.Device user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms identified were additional surgical procedures times three, hemodynamic instability, hemorrhagic shock, and abnormal blood loss.Post operatively the patient had abdominal compartment syndrome with large retroperitoneal hematoma, mesenteric tear, right iliac artery bleeding and ileum resection.The etiology of these events is unclear.The final patient status was reported as discharged to skilled nursing facility post operative day 16 and discharged to home post operative day 58.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: b5: describe event or problem has been updated.D6b: explant date has been updated.G3: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• 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: 20325324
• Report Number: 3008011247-2024-00104
• Device Sequence Number: 8005996
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980E1
• UDI-Public: +M701TVAB2980E1/$$3180604FS03201521$
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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): 09/09/2024

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: 06/04/2018
• Device Model Number: TV-AB2980-E
• Device Lot Number: FS032015-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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, LOT # FF082515-01.; OVATION PRIME ILIAC LIMB, LOT # FS080514-44.; OVATION PRIME ILIAC LIMB, LOT # FS102813-39.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male