MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number TV-AB3480-J

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During the initial implant, a palmaz was also used and the procedure ended with an indeterminate endoleak.The physician followed up with a two (2) week ct and elected to watch it as a persistent type 1a and patent ima with an endoleak type 2 was present.A 3 month follow up ct scan showed a persistent leak with no change, the aneurysm was noted to be smaller.On (b)(6) 2018, the patient underwent a coiling.It was reported that the patient is doing well post procedure.

Manufacturer Narrative

Based on the clinical assessment performed the type ia endoleak was confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms identified were arterial-venous fistula.A root cause cannot be determined for the type 1a endoleak.The final patient status was reported to be doing well post an endovascular intervention.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7658743
• MDR Text Key: 113027352
• Report Number: 3008011247-2018-00157
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3190520FS030216733
• Combination Product (y/n): N
• PMA/PMN Number: P0120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/20/2019
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS030216-73
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION LIMB-LOT: FS010518-32; OVATION LIMB-LOT: FS020218-69; OVATION LIMB-LOT: FS120517-29; OVATION LIMB-LOT: FS010518-32; OVATION LIMB-LOT: FS020218-69; OVATION LIMB-LOT: FS120517-29
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR