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

Model Number	TV-AB2680-N
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/09/2020
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 alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately three weeks post initial procedure the physician reported that the patient had some right leg discomfort.A commuted tomography angiogram (cta) showed that the right limb of the alto aortic body may be kinked due to angle of the aorta.The physician elected to add a balloon expandable stent to right limb of aortic body.Patient is still exhibiting diminished to no pulses.The physician has no plans to re-intervene the patient is home and doing well.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 buckling of the right limb of the aortic body event is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the right iliac limb leg of the aortic body was left compressed at the index procedure causing a disruption in blood flow over time.The failure of placing a supportive stent at the time of the index procedure likely contributed to the reported event.These findings were discovered during an examination of operative reports dated (b)(6) 2020.The most likely causation for the reported event is user related.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was awaiting a fem-fem bypass procedure.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: g4: awareness date.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10782650
• Report Number: 3008011247-2020-00124
• Device Sequence Number: 3629514
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680N1
• UDI-Public: +M701TVAB2680N1/$$3230728FS07242009F
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 07/28/2023
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS072420-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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 IX ILIAC LIMB - FS060320-25; OVATION IX ILIAC LIMB - FS111218-32; OVATION PRIME FILL POLYMER - FF060320-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR