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

Model Number B-50000

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 10/23/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "deflation and difficulty with fill tube" are as follows: "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, 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: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Deflation and subsequent replacement." "deflated device should be removed promptly." warnings and precautions: proper positioning of the placement catheter assembly and the bib¿ system balloon within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.The orbera¿ intragastric balloon system is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.Note: if the balloon becomes separated from the sheath prior to placement, do not attempt to use the balloon or reinsert the balloon into the sheath.Note: during the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: rapid fill rates will generate high pressure which can damage the orbera¿ intragastric balloon system valve or cause premature detachment.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint and product will be monitored as appropriate.Additional information: the device has not been returned for analysis.A device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number af04149.

Event Description

The balloon was leaking and the fill tube could not be removed, the balloon was removed for patient safety.A backup device was used 15 days after first implant.

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "deflation and difficulty with fill tube" are as follows: "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, 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: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Deflation and subsequent replacement." "deflated device should be removed promptly." warnings and precautions: proper positioning of the placement catheter assembly and the bib¿ system balloon within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.The orbera¿ intragastric balloon system is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.Note: if the balloon becomes separated from the sheath prior to placement, do not attempt to use the balloon or reinsert the balloon into the sheath.Note: during the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: rapid fill rates will generate high pressure which can damage the orbera¿ intragastric balloon system valve or cause premature detachment.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint and product will be monitored as appropriate.Additional information: the device has not been returned for analysis.A device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number af04149.

Event Description

The balloon was leaking and the fill tube could not be removed, the balloon was removed for patient safety.A backup device was used 15 days after first implant.

Manufacturer Narrative

Supplement # 1 medwatch submitted to the fda on 10/jan/2022.A device history record (dhr) review was performed for reporting purposes.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number af04149.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 28/dec/2021.A non-inflated balloon returned with the fill tube tip connected into the slit valve.There is biocarb present and the sheath is present on the shell.The end of the balloon was clamped onto the pull force equipment, and it met minimum requirements.An attempt was made to inflate the balloon; however, the balloon did not inflate, and the fill tip disconnected from the slit valve.The sheath was manually removed to gather additional information from the device.The fill tip was measured using a pin gauge and it met specifications.The balloon thickness was measured and met specifications.The complaint has been verified as the pressure to inflate the balloon exceeded requirements.Lab analysis was able to replicate the reported events of "difficulty with fill tube; obstruction of flow", as the fill pressure exceeded minimum requirements.The user effects of "difficulty with fill tube; obstruction of flow" are known and labeled possible adverse event.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer (Section G): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 12960536
• MDR Text Key: 285937113
• Report Number: 3006722112-2021-00118
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(17)20221106(10)AF04149
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF04149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• 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 Sex: Female