MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR, INC) OVATION IX; MAIN BODY

Model Number TV-AB2680-J

Device Problems Material Invagination (1336); Leak/Splash (1354); Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); Peripheral Vascular Disease (2002)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

Event Description

An ovation ix was initially implanted.The final angiogram showed the presence of a type ia endoleak.The physician elected not to treat the endoleak with a palmaz, and rather monitor the patient at the one (1) month follow-up.A re-intervention was performed on (b)(6) 2018 successfully resolving the endoleak.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.

Manufacturer Narrative

Based on description of the event and medical information available, clinical assessment confirmed the reported event of the intraoperative and persistent post procedure type ia endoleak.In addition, incomplete seal ring filling (invagination) was identified.These events were most likely user related due to the placement of an oversized stent.Procedure related harms included type ii endoleaks (a type ii endoleak is not device related rather anatomy related), and an arterial venous fistula between the fourth lumbar artery and the inferior vena cava which could only be observed after the stent was placed.The cause of the short segment occlusion of the left superior femoral artery and popliteal artery is anatomy related.The final patient status post the secondary repair one month post implant, could not be determined.The patient was discharged from the hospital in an unknown condition five days post surgical/endovascular repair, with persistent type ia and probable type ii endoleaks.Clinical assessment also determined that there was evidence to reasonable suggest left femoral and popliteal segmental occlusions and stenosis of the right iliac artery based on review of the 1 month post implant ct scan and angiogram.After review of the operative note and angiogram of the 1 month post implant repair clinical assessment determined that there was evidence to reasonable suggest: planned surgical right common femoral artery patch endartarectomy and repair performed with a non-endologix device resulting in a persistent intraoperative type ib endoleak (non-endologix device related).The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR, INC); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8100049
• MDR Text Key: 128214878
• Report Number: 3008011247-2018-00246
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3210622FS06151839B
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

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: Health Professional
• Device Expiration Date: 06/22/2021
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS061518-39
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS060518-50).; OVATION IX ILIAC LIMB (LN FS061218-27).
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR