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

Model Number B-50012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Additional information regarding this late medwatch report: during a february 2019 internal review of post-market surveillance data for all apollo products, apollo executive management was made aware that complaints associated with the ce marked orbera365 (12-month intragastric balloon) were not being assessed for reportability consistent with the requirements of 21 cfr 803.Consideration for reportability in the us was incorrectly established based on the difference in the indications for use (i.E.12-month placement vs 6-month placement) vs considerations for 'similar devices' marketed by apollo.The orbera365 12-month intragastric balloon is a 'similar device' as compared to the orbera 6-month balloon approved via pma p140008, and as such, complaints will be assessed for mdr reportability going forward.The reporter was not able to indicate the device serial and lot number.Apollo endosurgery has requested further information on the reported event of pulmonary embolism.To date, apollo has not received the requested information.The device has not been returned for analysis.As apollo concludes that the root cause for this incident is unknown, with limited information provided from the reporter, we cannot ascertain an appropriate risk probability.In reviewing the risk documentation, "pulmonary embolism" is currently captured in the application failure modes and effects analysis (afmea) related to placement of the balloon with a contraindication ("any other medical condition that would not permit elective endoscopy such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac and/or pulmonary disease").As there is no definitive information in the complaint related to the cause of the pulmonary embolism reported, the risk documentation does not need to be updated at this time.A review of the device labeling notes the following: warnings and precautions: 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.

Event Description

Reported as: a patient with the orbera365 intragastric balloon had developed a pulmonary embolism.The device was removed.

• Brand Name: ORBERA365 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 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8691730
• MDR Text Key: 147743985
• Report Number: 3006722112-2019-00085
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF01633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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
• Treatment: ESCITALOPRAM 5 MG ONCE DAILY; LERGIGAN FORTE (PROMETHAZINE) 50 MG; LEVOTHYROXINE 100 MCG ONCE DAILY
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 72