MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA BALLOON; INTRAGASTRIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 10/26/2016

Event Type  Injury  

Event Description

Orbera balloon migration with gastric outlet obstruction and damage to stomach.Pt had gastric volume of 2600cc plus 600cc balloon at removal 2 days after placement.Severe traumatic injury to lumen of stomach.

• Brand Name: ORBERA BALLOON
• Type of Device: INTRAGASTRIC IMPLANT
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 6069085
• MDR Text Key: 58975619
• Report Number: MW5065728
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 115