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

Model Number	TV-AB2980-N
Medical Device Problem Codes	Use of Device Problem (1670); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in the 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
During the initial implant of the ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa), the physician was unable to cannulate the contralateral limb.After several hours of trying multiple techniques the physician opted to abort the procedure.Only the aortic main body and one (1) limb was implanted.An intervention is being planned and the patient is being monitored.
Event or Problem Description
During the initial implant of the ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa), the physician was unable to cannulate the contralateral limb.After several hours of trying multiple techniques the physician opted to abort the procedure.Only the aortic main body and one (1) limb was implanted.An intervention is being planned and the patient is being monitored.Updated information: an intervention was not performed per family's decision.It was reported that the patient expired on an unknown date due to a myocardial infraction (mi).
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 the inability to cannulate the contralateral limb is unconfirmed.This is not consistent with the reported adverse event/incident.The most likely causation for the inability to cannulate the contralateral limb is due to tortuousity of bilateral iliacs as well as the off label nature of the left common iliac artery (distal diameter 45.9mm should be 8-25mm) likely contributed to the reported event.The distal calcifications also could have contributed to the event (cautionary product use condition).The patient expired due to a myocardial infarction (mi).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.
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 the inability to cannulate the contralateral limb is unconfirmed.This is not consistent with the reported adverse event/incident.The most likely causation for the inability to cannulate the contralateral limb is due to tortuousity of bilateral iliacs as well as the off label nature of the left common iliac artery (distal diameter 45.9mm should be 8-25mm) likely contributed to the reported event.The distal calcifications also could have contributed to the event (cautionary product use condition).The final patient status was not reported.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.Correction: g1/g2: contact office - name has been updated.G4: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION ALTO
• Common Device Name: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11273086
• Report Number: 3008011247-2021-00010
• Device Sequence Number: 4607353
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980N1
• UDI-Public: +M701TVAB2980N1/$$3231014FS10122021Z
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/06/2021

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: 10/14/2023
• Device Model Number: TV-AB2980-N
• Device Catalogue Number: TV-AB2980-N
• Device Lot Number: FS101220-21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/05/2021; 03/22/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/22/2021; 03/23/2021
• 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: FILL POLYMER, LOT#FF010920-01.; ILIAC LIMB, LOT#FS052120-13.; FILL POLYMER, LOT # FF010920-01; ILIAC LIMB, LOT # FS052120-13
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 84 YR