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

Model Number	TV-AB2680-N
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 treated for an abdominal aortic aneurysm (aaa) with the ovation alto abdominal aortic aneurysm stent.Fourteen (14) days post initial procedure, the patient presented with bilateral renal stenosis which the physician believes is due to the suprarenal portion of the stent.The patient is currently stable and no re-intervention is planned at this time.
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.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 renal stenosis event/incident was refuted.There was adequate renal flow post (evar) endovascular aneurysm repair.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak of the lumbar artery occurred.The most likely causation for the reported event is anatomy-related due to the type ii endoleak.The final patient status was reported as being discharged home stable on the second post-operative day.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 treated for an abdominal aortic aneurysm (aaa) with the ovation alto abdominal aortic aneurysm stent.Fourteen (14) days post initial procedure, the patient presented with bilateral renal stenosis which the physician believes is due to the suprarenal portion of the stent.The patient is currently stable and no re-intervention is planned at this time.Additional information: the renal stenosis event/incident was refuted.There was adequate renal flow post (evar) endovascular aneurysm repair.The clinical assessment determined that there was evidence to reasonably suggest a type ii endoleak of the lumbar artery occurred.As a type ii endoleak is anatomy-related and is not device related.This event is no longer reportable to the fda as there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• 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: 11033151
• Report Number: 3008011247-2020-00147
• Device Sequence Number: 1265304
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680N1
• UDI-Public: +M701TVAB2680N1/$$3230810FS080720077
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/24/2020

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: 08/10/2023
• Device Model Number: TV-AB2680-N
• Device Catalogue Number: TV-AB2680-N
• Device Lot Number: FS080720-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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, SN (B)(6); OVATION IX ILIAC LIMB, SN (B)(6); OVATION IX ILIAC LIMB, SN (B)(6); FILL POLYMER, SN (B)(4); OVATION IX ILIAC LIMB, SN (B)(4); OVATION IX ILIAC LIMB, SN (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR