MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for ORBERA? INTRAGASTRIC BALLOON SYSTEM B-4800 manufactured by Apollo Endosurgery, Inc..
[182191148]
Initial medwatch sent to the fda. 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 "pain", "ischemia", "nausea", "vomiting", "early removal", "aspiration" and "necrosis" as follows: precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain. Patients will need to immediately contact their physician for any severe or unusual symptoms. Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping. Food digestion may be slowed during this adjustment period. These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications. Typically the stomach acclimates to the presence of the device within the first 2 weeks. In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera? Placement). Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms. The physiological response of the patient to the presence of orbera? 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. Patients need to be evaluated and the device removed at or within 6 months of placement. Clinical data does not exist to support use of an individual orbera? Beyond 6 months. 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 - possible complications of the use of orbera? Include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon. Continuing nausea and vomiting. This could result from direct irritation of the lining of the stomach, delayed gastric emptying and/or the balloon blocking the outlet of the stomach. It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus. Abdominal or back pain; either steady or cyclic.
Patient Sequence No: 1, Text Type: N, H10
[182191149]
Reported as: patient presented pain, nausea, vomiting, and aspiration. The patient presented some mucosal hemorrhage during balloon removal. Images confirmed ischemic injury and mucosal necrosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00018 |
| MDR Report Key | 9747063 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-01-25 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-01-25 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | CS |
| Manufacturer Country | US |
| Manufacturer G1 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, CS |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORBERA? INTRAGASTRIC BALLOON SYSTEM |
| Generic Name | INTRAGASTRIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-02-24 |
| Model Number | B-4800 |
| Catalog Number | B-4800 |
| Lot Number | AF02815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-24 |