MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC LAP-BAND AP SYSTEM STANDARD; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number AP STANDARD

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

Lap gastric banding device placed many years prior.Adjustment done several years ago.Per history, a year ago there has been evidence of band slippage on ugi.A few months ago, the patient underwent laparoscopic removal of eroded adjustable gastric band with omental patch repair of gastric erosion.Excerpts from operative report: careful dissection revealed that the lap band had eroded into the stomach with the tubing emerging through the gastric wall.The band was mobilized to expose the buckle.The band was unbuckled and the band was found to be entirely inside the gastric lumen with a posterior mucosal bridge.The band was removed from the stomach.The tubing was cut and the band removed from the abdomen.Grossly, the band had chronic changes due to gastric acid exposure.The gastric erosion site was then repaired.

• Brand Name: LAP-BAND AP SYSTEM STANDARD
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 6784261
• MDR Text Key: 82362028
• Report Number: 6784261
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AP STANDARD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2017
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NONE KNOWN
• Patient Age: 57 YR
• Patient Weight: 96