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

Model Number	TV-AB2680-E
Medical Device Problem Codes	Complete Blockage (1094); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942)
Date of Event	06/09/2021
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 an ovation prime main body and (2) two ovation prime iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately (5) five years after the post-initial procedure, an endoleak (indeterminate origin) was identified.The physician brought the patient in for an angiogram on (b)(6) 2021 but upon angiogram imagining no 1a, 3a, or type 2 endoleak was found.The patient was reported to be doing fine and is currently being monitored.
Event or Problem Description
The patient was initially implanted with an ovation prime main body and (2) two ovation prime iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately (5) five years after the post-initial procedure, an endoleak (indeterminate origin) was identified.The physician brought the patient in for an angiogram on (b)(6) 2021 but upon angiogram imagining no 1a, 3a, or type 2 endoleak was found.The patient was reported to be doing fine and is currently being monitored.Additional information: internal clinical evaluation shows reasonable evidence to suggest left limb occlusion with lower leg ischemia and an additional endovascular procedure immediately post operatively following pressure held at the procedure site.
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 indeterminate endoleak was found to be a type 2 endoleak of the lumbar artery.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest left limb occlusion with lower leg ischemia and an additional endovascular procedure immediately post operatively following pressure held at the procedure site.The holding of pressure in a noted severely diseased vessel could have contributed to the ischemic event.Perfusion to the limb did not occur until the diseased femoral artery was treated.The most likely causation for the type 2 endoleak is anatomy related.The final patient status was discharged in stable condition.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.G4: date received by manufacturer has been updated.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
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 indeterminate endoleak was found to be a type 2 endoleak of the lumbar artery.This is not consistent with the reported adverse event/incident.The most likely causation for the type 2 endoleak is anatomy related.The clinical evaluation also shows reasonable evidence to suggest left limb occlusion with lower leg ischemia and an additional endovascular procedure immediately post operatively following pressure held at the procedure site.The holding of pressure in a noted severely diseased vessel could have contributed to the ischemic event.Procedure-related harms of the event could not be determined with the medical records available for review.The final patient status was discharged in stable condition.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.
Event or Problem Description
The patient was initially implanted with an ovation prime main body and (2) two ovation prime iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately (5) five years after the post-initial procedure, an endoleak (indeterminate origin) was identified.The physician brought the patient in for an angiogram on (b)(6) 2021 but upon angiogram imagining no 1a, 3a, or type 2 endoleak was found.The patient was reported to be doing fine and is currently being monitored.Additional information: internal clinical evaluation shows reasonable evidence to suggest left limb occlusion with lower leg ischemia and an additional endovascular procedure immediately post operatively following pressure held at the procedure site.The clinical assessment also determined there was an additional endovascular procedure done (multiple sac coiling) for the type 2 endoleak.

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12071552
• Report Number: 3008011247-2021-00061
• Device Sequence Number: 4752641
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680E1
• UDI-Public: +M701TVAB2680E1/$$3180630FS041315440
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/09/2021

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: 06/30/2018
• Device Model Number: TV-AB2680-E
• Device Catalogue Number: TV-AB2680-E
• Device Lot Number: FS041315-44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 09/08/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/13/2021; 10/12/2021
• 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 290-0072-01-02.; OVATION PRIME ILIAC LIMB 290-0054-08-01.; OVATION PRIME ILIAC LIMB 290-0059-03-01.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR