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

Model Number TV-AB2980-E

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.During cannulation of the aortic body stent graft, the physician inadvertently deployed both limbs into the ipsilateral gate.A balloon was used to pull the incorrectly placed contralateral iliac limb into the aneurysm sac and a second limb was deployed into the intended location and extended into the common iliac artery with an iliac limb extension.A balloon expandable stent was placed inside the ipsilateral limb to successfully gain full apposition between the iliac limb and the ipsilateral gate.The aneurysm was successfully excluded with no patient sequelae.

Manufacturer Narrative

Udi # (b)(4).Remains implanted.

• Brand Name: OVATION PRIME 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 ; 7075438835
• MDR Report Key: 4477087
• MDR Text Key: 5566789
• Report Number: 3008011247-2015-00010
• Device Sequence Number: 1
• Product Code: MIH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2015

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: 09/25/2017
• Device Model Number: TV-AB2980-E
• Device Catalogue Number: TV-AB2980-E
• Device Lot Number: FS092314-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• 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
• Treatment: BSC EXPRESS STENT
• Patient Outcome(s): Other
• Patient Age: 73 YR