MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number TV-IL1412120-J

Device Problems Complete Blockage (1094); Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2021

Event Type  Injury  

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 Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately two (2) weeks post initial implant there was a limb occlusion of the graft noted.The physician elected to implant two (2) 13x10 gore viabahn (non-endologix) stents to resolve this event.The patient was reported as doing well post secondary procedure.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately two (2) weeks post initial implant there was a limb occlusion of the graft noted.The physician elected to implant two (2) 13x10 gore viabahn (non-endologix) stents to resolve this event.The patient was reported as doing well post secondary procedure.Additional information per clinical assessment: the reported limb occlusion was refuted, and rather severe stenosis with buckling of the proximal right limb was confirmed.

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.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 right limb occlusion was found to be severe stenosis and buckling of the proximal right limb.This is not consistent with the reported adverse event/incident.The most likely causation for the reported event is anatomy related due to the aortic angulation of 57 degrees.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported to be doing well.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-updated.G4: date received by manufacturer-updated.H6: device code: remove code 1094.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Type of Device: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12361385
• MDR Text Key: 267930490
• Report Number: 3008011247-2021-00096
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412120J1
• UDI-Public: +M701TVIL1412120J1/$$3240309FS03082143H
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: TV-IL1412120-J
• Device Catalogue Number: TV-IL1412120-J
• Device Lot Number: FS030821-43
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTO MAIN BODY, LOT # FS040721-01; OVATION IX ILIAC LIMB, LOT # FS041621-06; OVATION PRIME FILL POLYMER, LOT # FF111120-01; ALTO MAIN BODY, LOT # FS040721-01; OVATION IX ILIAC LIMB, LOT # FS041621-06; OVATION PRIME FILL POLYMER, LOT # FF111120-01
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR