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

Model Number	TV-AB2380-E
Medical Device Problem Codes	Complete Blockage (1094); Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); Thrombosis/Thrombus (4440)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an ovation prime stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented at the doctor's office in a wheelchair and was sent to the hospital to be admitted.It was reported that the patient had been lost to follow up and had stopped taking their medication (xaralto).The graft was found to have thrombosed and the clot looked chronic.The physician elected to perform an open thrombectomy followed by implant of an ovation ix 12x120 iliac limb in the right common iliac artery / external iliac artery (cia/eia), with right to left fem/fem bypass to resolve this event.The patient was discharged two (2) days later.
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 an ovation prime stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented at the doctor's office in a wheelchair and was sent to the hospital to be admitted.It was reported that the patient had been lost to follow up and had stopped taking their medication (xaralto).The graft was found to have thrombosed and the clot looked chronic.The physician elected to perform an open thrombectomy followed by implant of an ovation ix 12x120 iliac limb in the right common iliac artery / external iliac artery (cia/eia), with right to left fem/fem bypass to resolve this event.The patient was discharged two (2) days later.Additional information: it was reported that the patient had been lost to follow up and stopped taking their blood thinner medication.Additionally, the index procedure was off label as there was no abdominal aortic aneurysm.
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 graft thrombosis, thrombectomy, fem-fem bypass with additional endovascular procedure event are unconfirmed due to lack of comparative imaging.This is not 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.It was reported that the patient had been lost to follow up and stopped taking their blood thinner medication.The index procedure was off label as there was no abdominal aortic aneurysm.The final patient status was not reported as discharged home on postoperative day two.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.G3: date received by manufacturer has been updated.H6: investigation finding: remove code 3233.H6: investigation conclusion: 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: 15324291
• Report Number: 3008011247-2022-00103
• Device Sequence Number: 5226831
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380E1
• UDI-Public: +M701TVAB2380E1/$$3180428FS03131501
• 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
• 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): 08/15/2022

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: 04/28/2018
• Device Model Number: TV-AB2380-E
• Device Catalogue Number: TV-AB2380-E
• Device Lot Number: FS031315-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• 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 # FF052215-01; OVATION PRIME ILIAC LIMB, LOT # FS021015-06; OVATION PRIME ILIAC LIMB, LOT # FS050714-14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown