MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC ORBERA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number UNKNOWN

Device Problems Inflation Problem (1310); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

The balloon overinflated and lead to gastric outlet obstruction.The balloon was emergently removed and patient did well immediately after removal.

• Brand Name: ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC; 1120 s capital of texas hwy; bldg 1, suite 300; austin TX 78746
• MDR Report Key: 7731205
• MDR Text Key: 115389420
• Report Number: 7731205
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 06/29/2018
• Date Report to Manufacturer: 07/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA