MAUDE Adverse Event Report: GORE GORE; EXCLUDER AAA ENDOPROSTHESIS

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/05/2016

Event Type  Injury  

Event Description

Pt underwent endovascular aortic aneurysm repair for repair of aaa.Procedure went well.Pt went for f/u ct scan on (b)(6) 2016 and on ct-scan, a foreign body was seen that was consistent with the tip of the stent deployment device.Pt was admitted (b)(6) 2016 for removal of foreign body.

• Brand Name: GORE
• Type of Device: EXCLUDER AAA ENDOPROSTHESIS
• Manufacturer (Section D): GORE
• MDR Report Key: 5982932
• MDR Text Key: 55895318
• Report Number: MW5065051
• Device Sequence Number: 1
• Product Code: PFV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR