MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)

Patient Problems Weight Changes (2607); Patient Problem/Medical Problem (2688)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda.A review of the device labeling notes the following: the current orbera365® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "unsatisfactory weight loss" and "other - migration" as follows: precautions: the physiological response of the patient to the presence of orbera365¿ may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications of the use of orbera365¿ include: insufficient or no weight loss.Warnings: patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically as this may be indicative of a balloon deflation.Warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).The physiological response of the patient to the presence of the orbera365¿ system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications: possible complications of the use of the orbera365¿ system include: balloon deflation and subsequent replacement.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint for this product will be reviewed as appropriate in the complaints analysis meeting (cam).

Event Description

Patient regained weight.Balloon deflated and migrated.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, tx
• MDR Report Key: 9843809
• MDR Text Key: 191007626
• Report Number: 3006722112-2020-00039
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2020

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: 06/04/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF01975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 99