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

Model Number	TV-AB2380-N
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 being treated for an abdominal aortic aneurysm (aaa) with implant of an ovation alto abdominal stent graft and two ovation ix iliac limbs.Post deployment and polymer fill an intraoperative type 1a endoleak was identified.An attempt was made to balloon the type 1a endoleak; however, the integral balloon of the ovation alto delivery system would not advance past the significant angle at the graft bifurcation.Patient is stable and will continue to be monitored.
Additional Manufacturer Narrative
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 could not be completed.No medical records nor medical imaging relevant to the adverse event/incident was received by endologix.Due to the absence of medical records and reported medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as being stable.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: d3 manufacturer, g1 reporting entity, h6 device codes (as evaluated); remove 2920, h6 evaluation result codes; remove 3233, h6 evaluation conclusion codes; remove 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: 10627665
• Report Number: 3008011247-2020-00110
• Device Sequence Number: 14104398
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380N1
• UDI-Public: +M701TVAB2380N1/$$3230720FS07162010/
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/14/2020

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: 07/20/2023
• Device Model Number: TV-AB2380-N
• Device Catalogue Number: TV-AB2380-N
• Device Lot Number: FS071620-10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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 (LN FS060520-18); OVATION IX ILIAC LIMB (LN FS110919-09); OVATION PRIME POLYMER FILL (LN FF040320-01); OVATION IX ILIAC LIMB (LN FS060520-18); OVATION IX ILIAC LIMB (LN FS110919-09); OVATION PRIME POLYMER FILL (LN FF040320-01)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR