MAUDE Adverse Event Report: ALLERGAN VG LAP BAND SYSTEM

Model Number B2250

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 07/03/2016

Event Type  Injury  

Event Description

Pt had a laparoscopic adjustable gastric band procedure where an 11cm vanguard band was placed on (b)(6) 2007.The pt presented to the hospital on (b)(6) 2016 with a gi bleed.He was placed on iv fluids, hemoglobins were trended and a protonix infusion was started, gi was consulted and an egd was performed.The egd showed that the lap band had perforated through the gastric wall causing the bleeding.The pt was transferred to icu and a surgical consult was placed.Surgery decided to do a combined laparoscopic and endoscopic approach to remove the band and tubing.The band and tubing had eroded into the stomach and a portion of the duodenum.The pt had extensive adhesions.The band and tubing were removed on (b)(6) 2016.The pt's hemoglobin dropped to 7.8.He continued to improve and he was discharged home on (b)(6) 2016.

• Brand Name: VG LAP BAND SYSTEM
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN; santa barbara CA
• MDR Report Key: 5857236
• MDR Text Key: 51833835
• Report Number: 5857236
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/21/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: B2250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2016
• Distributor Facility Aware Date: 07/03/2016
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR