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); Leak/Splash (1354); Off-Label Use (1494)

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

Event Date 04/20/2017

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.Patient came in for a routine follow-up approximately 2 months post-op where the physician observed a type ia endoleak.Physician elected to re-intervene and successfully resolved the 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 event of the type ia endoleak and the secondary procedure.The patient reported to be doing well post procedure could not be confirmed.Additionally, infolding of the device was identified.The most likely cause of the device loss of seal due to slight infolding was the intentional use of a non recommended product by the physician.There was no procedure-related error or cautionary or off-label product use detected.Associated clinical harms for this device failure included: type ia endoleak and a secondary endovascular intervention.The final patient disposition was reported to be doing well.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: 6569543
• MDR Text Key: 75263176
• Report Number: 3008011247-2017-00239
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3200111FS09201646/
• 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: 04/20/2017

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: FS092016-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• 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): Other
• Patient Age: 75 YR