Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM US
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM US Back to Search Results
Model Number B-4800
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Gastritis (1874); Inflammation (1932); Nausea (1970); Vomiting (2144); Weakness (2145)
Event Date 10/06/2019
Event Type  Injury  
Manufacturer Narrative
The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "inflation", "vomiting", "nausea", "dehydration", "bloating" as follows: warnings and precautions the physiological response of the patient to the presence of the orbera® 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, gastric and esophageal perforation, and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients with an intragastric balloon that present with severe abdominal pain that have a negative endoscopy and x-ray may additionally require a ct scan to definitively rule out a perforation.Complications: adverse health consequences resulting from weight loss.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 or as a result of 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.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.
 
Event Description
Company representative reported via product field notes (pfn), "when i had first talked to the patient during our first coaching session on (b)(6) 2019, 8 days after balloon insertion, [the patient] had been having n/v since procedure but was feeling better the day of our session.[the patient] did get an injection of zofran at the dr's office (not sure of that date) which helped [them] feel better.At the time of our 1st session [the patient] said that [they were] not able to take in much fluids for hydration, and had concentrated urine, so i advised [the patient] to contact her orbera provider as [they] may need some iv fluids.At that time [the patient] was on fulls/pureed foods.I discussed tips on advancing food textures as [they were] starting to feel better, discussed foods that delay gastric emptying if [the patient] continues to not feel good, and foods to decrease reflux.On 10/18/2019 i sent [the patient] a message through the apollo care platform checking in to see how [they were] doing and if [the patient] was able to increase [their] fluids and i got a message back that [they] could not eat much as was feeling a lot of stomach gas which [they] felt could be hindering [their] intake of food/fluids.I recommended trying otc gas-x or beano, but that if [they were] still having symptoms, and still not able to take in much food/fluids, then to contact [their] orbera provider.I also gave [the patient] the medical affairs hotline.[the patient] missed the next coaching session on (b)(6) 2019 and i looked at [their] food journal and [their] weight loss and noticed very little intake and a lot of weight loss so i emailed [their] orbera provider to let them know and that they may want to contact [the patient] to see how [they were] doing.[the patient] rescheduled [their] coaching session and i had [the patient] on (b)(6) 2019.I found out [the patient] was advised to go to urgent care on (b)(6) for iv fluids.[the patient] receive lr.[the patient] needed k+ and they didn't have it so they sent [the patient] to the hospital where they gave [the patient]lr with k+.[the patient] was in the hospital overnight on (b)(6) 2019.On (b)(6) 2019 [the patient] got more iv fluids at the dr's office, just ns with iv zofran.[the patient] started reglan on (b)(6) 2019 prescribed 4x/day before meals, still take some pyrazole bid, and zofran prn.Last time [the patient] vomited was 2 days ago but [the patient] states [they have] been vomiting daily until then.[the patient] still has nausea frequently and mostly in the mornings.[the patient] is still only able to take in limited amount of overall fluids for hydration, around ~24 ounces.[the patient's] dr.Already talked to [the patient] about the possibility that they may need to remove the balloon if [their] symptoms continue with inability to increase intake.
 
Event Description
Additional information: "pt was admitted to the hospital as an inpatient on (b)(6) 2020 due to continued nausea and vomiting with electrolyte disturbances and patient complaints of weakness including tingling of face and hands.[the patient] was just discharged today on (b)(6) 2020.Patient also stated [they were] diagnosed with acute gastritis during this hospital stay.[the patient] also had their balloon removed on (b)(6) 2020.".
 
Manufacturer Narrative
Supplement #1 - submitted to the fda on 13/jan/2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORBERA INTRAGASTRIC BALLOON SYSTEM US
Type of Device
INTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. capital of texas hwy
bldg 1, ste. 300
austin TX 78746
MDR Report Key9583112
MDR Text Key180786331
Report Number3006722112-2019-00195
Device Sequence Number1
Product Code LTI
UDI-Device Identifier10811955020619
UDI-Public10811955020619
Combination Product (y/n)N
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberB-4800
Device Catalogue NumberB-4800
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GABAPENTIN; GERD (20 YRS); HYOCYAMINE; IBS-D (20 YRS); IVFLUIDS LR INCL K+ REPLACEMENTS; OMEPRAZOLE 20 MG BID; REGLAND4X/DAY; ZOFRAN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight88
-
-