MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365 INTRAGASTRIC BALLOON

Model Number B-50012

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda.The device was returned to the apollo device analysis laboratory on 05/aug/2020.Analysis of the device is ongoing.A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as.02% -.49% of complaints over units sold.A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote".Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides.

Event Description

"balloon hyperinflation at 8 months in the patient.".

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 08/oct/2020.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 5/august/2020.A deflated balloon with significant blue/green discoloration and unknown particles was returned.The fill tube was not returned for evaluation and there are several holes on the shell; therefore, no functional testing could be conducted.The complaint could not be verified due to the condition of the returned balloon.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 10420460
• MDR Text Key: 203335293
• Report Number: 3006722112-2020-00065
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF02832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METFORMIN, 800MG; METFORMIN, 800MG
• Patient Age: 45 YR