MAUDE Adverse Event Report: STENT

Device Problem Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Date 10/07/2010

Event Type  Injury  

Event Description

Transported to (b)(6) in (b)(6) from (b)(6) for repair of a non ruptured abdominal aortic aneurysm on (b)(6), 2010.Met vascular surgeon (b)(6) , who told me that he had examined my chart and reports from (b)(6) and that we needed to repair the aneurysm and that i had a 97 percent chance of having a good procedure.I agreed to the surgery.(b)(6) performed the aaa repair, where i believe stents were installed.I awoke from the surgery paralyzed from the ribcage down.Neither (b)(6) nor (b)(6) has been forthcoming about what caused my paralysis.

• Brand Name: STENT
• Type of Device: STENT
• MDR Report Key: 3770889
• MDR Text Key: 4442267
• Report Number: MW5035748
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 66 YR
• Patient Weight: 85