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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Dehydration (1807); Edema (1820); Fatigue (1849); Gastritis (1874); Ischemia (1942); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067); Vomiting (2144); Hernia (2240); Hypovolemia (2243); Peritonitis (2252); Anxiety (2328); Malaise (2359); Obstruction/Occlusion (2422); Irregular Pulse (2469); Abdominal Distention (2601); Weight Changes (2607); Constipation (3274)
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Event Type
Injury
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Manufacturer Narrative
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This event was reported by the patient's spouse.To date, apollo has been unable to confirm the reported events with the patient's physician and unable to obtain the device nor any further device information.Device labeling addresses the reported event 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 of the use of orbera® include: gastric outlet obstruction.A partially-filled balloon (i.E., <400 cc), or a leaking balloon could lead to gastric outlet obstruction, requiring balloon removal.It is also possible for a fully inflated (400-700 cc) balloon to lodge itself in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require surgical removal.Abdominal or back pain, either steady or cyclic.Blockage of food entering into the stomach.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.
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Event Description
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Reported as: the spouse of a patient with the orbera intragastric balloon reported "3 weeks ago my [spouse] started having severe pain.Took my [spouse] to the emergency room, because [spouse] was not able to tolerate the pain any longer.A scan performed, they said the stomach was swollen and [spouse] need to take medicine for the pain and rest.Last night [spouse] started again with severe pain.We went to hospital where they find out a hole in stomach were fluid was getting out because the balloon was stuck in the stomach impending the fluid going throw the pylorus.It was so swollen they had to take [spouse] to a different hospital where physician performed a surgery to remove the balloon cutting the stomach, because they could not inflate the stomach more to get it out endoscopically." reporter stated the hospital physician confirmed "balloon was attached to the walls of the stomach blocking the pylorus, the stomach was swollen and [removal was] performed with a pin nail hole.".
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Manufacturer Narrative
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Device labeling is addressed as follows: possible complications of the use of orbera® include: gastric outlet obstruction.A partially-filled balloon (i.E., <400 cc), or a leaking balloon could lead to gastric outlet obstruction, requiring balloon removal.It is also possible for a fully inflated (400-700 cc) balloon to lodge itself in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require surgical removal.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.Us pivotal study: us pivotal clinical study documents, the event of constipation experienced by 20%, dehydration experienced by 1.3%, gastritis experienced by 1.9% and the event of gastric perforation with sepsis and peritonitis was experienced by 0.6% of 160 participants.Contraindications: prior gastrointestinal or bariatric surgery.A large hiatal hernia or > 5cm hernia or <= 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.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.Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.The risk of obstructions may be higher in patients who have diabetes, a dysmotility disorder, or who have had prior abdominal or gynecological surgery, so this should be considered in assessing the risk of the procedure.Bowel obstruction can result in death.
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Event Description
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Additional information received via operative report: patient had worsening abdominal pain, transferred to hospital where computed tomography (ct) scan showed possible gastric perforation and free air.Patient experienced chest pain and back pain, endorsed nausea and non-bloody emesis, distension, palpitations, anxiety, fatigue, malaise, weight loss and constipation.Ct scan also demonstrated intragastric balloon mesenteric edema and stranding at grater curve, air in gastric wall versus flecks of free air and trace free fluid concerning for micro perforation.Patient's repeat labs were significantly altered with leukocytosis now to 18,000 acidosis by arterial blood gases (abg), chemistry and lactate and lipase now normalized to 41.Patient was given fluid/electrolyte for acidosis, dehydration and hypovolemia and sepsis.Patient had clinical peritonitis on exam-very tender in epigastrium and bilateral upper quadrants.Ct scan suggestive of air within gastric wall and possible walled off micro perforation presumed due to obstruction, ulceration or ischemia from intragastric balloon.There was no evidence of ulceration on completion of endoscopy.Patient had diagnostic laparoscopy, upper gastrointestinal (gi) endoscopy, transgastric removal of gastric balloon, oversew of perforation, closure of gastrotomy, and primary repair of recurrent small umbilical hernia.During the procedure physician had noted, "in the hyperemic portion of the stomach with the inflammatory peel which had been previously adherent to the anterior abdominal wall and omentum, found a small defect which was likely the etiology of the air in the gastric wall and flecks of free air which had been seen on the patient's ct." there was a significant amount of gastritis within the antrum.Post-operative diagnosis: walled off micro perforation of patient's gastric wall with free fluid in left upper quadrant.Left distal aspect of greater curve of fundus and adjacent adherent omentum indurated, thickened and adherent to anterior abdominal wall.Intragastric balloon noted to be lodged in gastric antrum both endoscopically and on intraoperative inspection, no evidence of ulceration on completion endoscopy, recurrent small umbilical hernia (repaired primarily).
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