MAUDE Adverse Event Report: ENDOLOGIX, INC. BODY AORTIC OVATION PRIMES 29MM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number TV-AB2980-J

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

During infrarenal abdominal aortic aneurysm repair and stent placement, a portion of the delivery system broke off and could not be retrieved.Fda safety report id # (b)(4).

• Brand Name: BODY AORTIC OVATION PRIMES 29MM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): ENDOLOGIX, INC. ; irvine CA 92618
• MDR Report Key: 10459605
• MDR Text Key: 204707219
• Report Number: MW5096297
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: TV-AB2980-J
• Device Lot Number: FS050120-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR