MAUDE Adverse Event Report: UNKNOWN; GASTRIC BAND AND PORT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Adhesion(s) (1695); Erosion (1750)

Event Date 01/21/2016

Event Type  Injury  

Event Description

Adjustable gastric band placed approximately 5 years ago.Patient seen approximately 5 years after implant for unsuccessful weight loss.Decision to convert to vertical roux en y.During surgery there was found: extensive adhesions where the band was eroding into the liver and stomach up to the liver, esophagus and omentum.

• Type of Device: GASTRIC BAND AND PORT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5488710
• MDR Text Key: 39949878
• Report Number: 5488710
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2016
• Device Age: 5 YR
• Date Report to Manufacturer: 03/01/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 98