MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION IX ABDOMINAL STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM

Model Number TV-AB3480-J

Device Problems Material Invagination (1336); Off-Label Use (1494)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The initial procedure went without issue and the post-operative ct showed no signs of a type 1a endoleak.One month post-op, the patient returned for a routine follow-up where physician observed a type 1a endoleak.A re-intervention was done where physician implanted a palmaz stent and successfully resolved the type 1a endoleak.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

Based on the description of the event and provided medical records, clinical assessment confirmed the reported events of the type ia endoleak, and secondary procedure.Additionally, clinical assessment identified type ii endoleaks at the ima and l4 lumbar artery, as well as infolding of the sealing ring.The most likely cause of the loss of seal is the infolding of the sealing ring in an angulated proximal neck (juxtarenal angulation of 77 degrees, off-label).There were no known procedure or user related issues or cautionary product use conditions related to this event.Associated clinical harms for this device included: type ia endoleak; secondary endovascular procedure of placing a self expanding stent across the sealing ring.The final patient disposition was discharged home on post operative day one in improved condition.There was no device related issue involving the type ii endoleak the cautionary product use conditions such as a patent ima and lumbar arteries, likely contributed to the clinical harm.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 ABDOMINAL STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer (Section G): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: alexis weil ; 3910 brickway blvd.; santa rosa, CA 95403
• MDR Report Key: 6594948
• MDR Text Key: 76126525
• Report Number: 3008011247-2017-00263
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3200124FS092616153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS092616-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR