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This event was reported by the patient's family member.To date, apollo has been unable to confirm the reported events with the patient's physician and the device has not been returned for analysis.Device labeling notes the following: 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 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.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 and back pain; either steady or cyclic.Acute pancreatitis.Death due to complications related to intestinal obstruction is possible.The event of impaired gastric emptying was reported in the (b)(6) clinical study and was experienced by 8.8% of the participants.Warnings: acute pancreatitis has been reported as a result of injury to the pancreas by the balloon.Patients experiencing any symptoms of acute pancreatitis (i.E.Acute abdominal pain, nausea or vomiting) should be counseled to seek immediate care.Endoscopic removal of orbera® must be completed in the presence of an empty stomach.Patients should be npo for a minimum of 12 hours prior to removal.If food is found in the stomach upon endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway.The risk of aspiration of gastric contents into the patient's lungs represents a serious risk which can result in death.
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Apollo endosurgery received a letter of request from the fda dated march 1, 2018 for additional information regarding voluntary mw5075363 - mdr report number 3006722112-2018-00090.(b)(4).Response to fda request: 1.Please provide the device implant and explant dates and/or the duration of implant time.If the implant was explanted, please provide the reason.Response: the balloon was placed on (b)(6) 2015 and removed on (b)(6) 2016.It was reported patient experienced "pulmonary embolism, nausea, fatigue, dizziness, edema around gallbladder, stomach debris and distention, abdominal and back pain, sepsis, elevated liver enzymes and needed dialysis." then "[the health care practitioner] removed the balloon." the exact reason for explant was not provided.2.Please provide a more complete description of this event including any relevant details surrounding the event.Response: apollo received voluntary mw5075363 from the patient's family member.It was reported, "[patient] had the orbera balloon placed on (b)(6) 2018.From this point, up until [patient's] death, our experience was rather traumatic and includes many details, but i will give a brief overview.Thirteen days after placement [patient] had a pulmonary embolism and spent 4 days in icu.Prior to this, [patient] was very healthy other than blood pressure issues, very active, loved to travel and was an elementary school counsellor.[patient] was discharged home after p.E.On xarel at which point i feel the balloon should have been removed - but it was not.As the weeks went on [patient] continued to get sicker with nausea, fatigue, dizziness - so much so that [patient] couldn't function in the mornings while trying to get ready for work.[patient] called the office that placed the balloon - they continued to explain this was all normal and they repeatedly called in meds for nausea.[patient] started having to miss work because [patient] was so weak and dizzy.[patient] was able to eat but 2 bites of food even 4 months after the procedure.Finally [patient] "was taken by ambulance to the er.[patient's] liver enzymes were extremely elevated.Further testing showed edema around the gallbladder.Stomach debris and distention." the patient then "began to complain of severe abdominal pain and back pain - the dr.Said they needed to check for pancreatitis.Before they were able to do so [patient] became septic and was rushed to icu.During this time [patient's] liver enzymes continued to rise and needed dialysis." the balloon was removed on (b)(6) 2016."the surgeon said they had a hard time getting to it b/c there was so much food in [patient's] stomach that had not digested and that the balloon had food stuck to the device.[patient] was then transferred to the hospital for a possible transplant but [their] body continued to get sicker." it was reported the patient passed away on (b)(6) 2016.The reporter "feels this device caused some serious digestive issues to occur with obstruction, etc.And per [patient's] medical records pancreatitis was also noted." medical information called the reporter and additional information was provided: the patient had been in contact by phone [to implanting physician's office] fairly often due to nausea and vomiting.The reporter said that the office kept telling [the patient] that the symptoms were to be expected and continued to prescribe phenergan and zofran but did not have [patient] come in.The reporter also said that [the patient] asked to have the balloon removed but the doctor wanted [patient] to keep with it.The reporter reiterated the events provided in the medwatch stating [implanting physician] did not remove the patient's balloon as the patient was at [another hospital] dealing with hepatic issues and dialysis.A bariatric surgeon removed the orbera.The patient was then sent to [another hospital] for a liver transplant.The doctors there did not feel [patient] was a candidate in [their] present state of health.The patient died at that hospital.The patient's spouse did not want an autopsy performed.Additional information provided: apollo's chief medical officer contacted the patient's implanting physician, who declined to discuss the reported event further.3.Please fully describe the reported device difficult to remove issue.Describe any relevant alarm states and visual and/or audible indicators the device should present when a malfunction of this nature occurs.Response: it was reported on the voluntary medwatch that the explanting physician experience difficulty "getting to [the balloon] b/c there was so much food in [patient's] stomach that it had not digested and that the balloon had food stuck to it that [physician] had to remove.[physician] said this was not typical for the removal process and that there should not be undigested food stuck to the device." as the events reported were not device issues but rather physiological events, there should not be any relevant alarm states and/or audible indicators the device would present.4.Please provide any evaluation of the event described in the medical device report by the attending physician, surgeon, hospital representative or health care professional.Response: apollo's chief medical officer then followed up with [implanting physician] who declined to discuss the event.Apollo did not have direct communication with any other health care professionals.The reporter stated they had a large box of [patient's] medical records.Medical information requested the patient's records from the reporter, however, the patient stated they were unsure about sending the actual documents but would provide what they feel is important.No patient records have been provided to apollo to date.5.Please provide the primary and secondary cause of death as it was reported by the patient's physician, as it appears in the medical record or as it is described in the autopsy report.Please include the information source used in your response.Response: the cause of death could not be determined at this time.The patient's spouse did not want an autopsy performed.This complaint is still under investigation.6.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device report are or are not attributable to the device.Response: as apollo endosurgery takes a conservative approach in the absence of information required to complete the investigation, these events are considered attributable to the device.Apollo attempted to obtain the medical records from the reporter, however the reporter preferred to summarize the information in the medical documents.The device will not be returned, and a device history record review is not possible for this complaint as the device and serial number are unknown.There was no information provided to apollo stating or suggesting the events were related to a device malfunction.7.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: a.An explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual response: a root cause for these events could not be determined at this time.The implanting physician declined to provide any information regarding this case.The device was not returned for evaluation.B.A complete description of investigation and analysis methodology(ies) used, response: this complaint is still under investigation.Apollo received a voluntary medwatch reported by patient's family member.In order to obtain additional information, apollo contacted the reporter.The reporter summarized the medical findings, but did not provide the actual paperwork.Apollo received permission to follow up with the patient's implanting physician.Apollo's chief medical officer then reached out to the implanting physician who declined to provide any information regarding this case.The device was not returned for evaluation.C.An identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and response: there were no specific failure modes identified as the root cause of the reported events remains inconclusive.The device was not returned for evaluation.D.Any conclusions reached based on the investigation and analysis results.Response: this complaint is still under investigation and analysis and is currently inconclusive.A conclusion has not been made at this time.The device was not returned for evaluation.8.Please provide a complete list of medical device reports (mdrs) that you have determined are related to problems/issues of pulmonary embolism, pancreatitis, inflammation of gallbladder or cholecystitis, gastric obstruction, sepsis, death, and dialysis.Please identify how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.That your firm has received in the past 2 years that are related to this same reported device problem.Response: apollo endosurgery has submitted the following mdrs for reports of pulmonary embolism, pancreatitis, inflammation of gallbladder or cholecystitis, gastric obstruction, sepsis, and/or death.Over the past 2 years, from march 1, 2016 through march 16, 2018, apollo has received one 1 complaint related to pulmonary embolism, 1 complaint related to pancreatitis, 1 complaint related to inflammation of gallbladder or cholecystitis, 4 complaints related to gastric obstruction, 3 complaints related to sepsis, and 8 complaints related to death.(b)(4)/ mdr number: 3006722112-2015-00599; pancreatitis (b)(4)/ mdr number: 3006722112-2016-00033; obstruction (b)(4)/ mdr number: 3006722112-2016-00034; death (b)(4)/mdr number: 3006722112-2016-00108; death (b)(4)/mdr number: 3006722112-2016-00127; pancreatitis (b)(4)/mdr number: 3006722112-2016-00150; death (b)(4)/mdr number: 3006722112-2016-00268; obstruction (b)(4)/mdr number: 3006722112-2016-00316; obstruction (b)(4)/mdr number: 3006722112-2016-00258; obstruction (b)(4)/mdr number: 3006722112-2016-00290; obstruction (b)(4)/mdr number: 3006722112-2016-00337; obstruction (b)(4)/mdr number: 3006722112-2016-00338; death (b)(4)/mdr number: 3006722112-2016-00359; obstruction (b)(4)/mdr number: 3006722112-2016-00384; obstruction (b)(4)/mdr number: 3006722112-2016-00386; obstruction (b)(4)/mdr number: 3006722112-2017-00004; obstruction (b)(4)/mdr number: 3006722112-2017-00017; obstruction (b)(4)/mdr number: 3006722112-2017-00056; obstruction (b)(4)/mdr number: 3006722112-2017-00300; obstruction (b)(4)/mdr number: 3006722112-2017-00084; obstruction (b)(4)/mdr number: 3006722112-2017-00083; pulmonary embolism (b)(4)/mdr number: 3006722112-2017-00052; obstruction (b)(4)/mdr number: 3006722112-2017-00148; death (b)(4)/mdr number: 3006722112-2017-00193; obstruction (b)(4)/mdr number: 3006722112-2017-00229; pancreatitis (b)(4)/mdr number: 3006722112-2017-00219; obstruction (b)(4)/mdr number: 3006722112-2017-00250; obstruction (b)(4)/mdr number: 3006722112-2017-00245; obstruction (b)(4)/mdr number: 3006722112-2017-00275; obstruction (b)(4)/mdr number: 3006722112-2017-00293; obstruction (b)(4)/mdr number: 3006722112-2017-00287; obstruction (b)(4)/mdr number: 3006722112-2017-00323; obstruction (b)(4)/mdr number: 3006722112-2017-00324; obstruction (b)(4)/mdr number: 3006722112-2017-00335; obstruction (b)(4)/mdr number: 3006722112-2017-00331; obstruction (b)(4)/mdr number: 3006722112-2017-00337; pancreatitis (b)(4)/mdr number: 3006722112-2017-00336; obstruction (b)(4)/mdr number: 3006722112-2017-00341; obstruction (b)(4)/mdr number: 3006722112-2017-00347; obstruction (b)(4)/mdr number: 3006722112-2017-00350; obstruction (b)(4)/mdr number: 3006722112-2017-00349; sepsis (b)(4)/mdr number: 3006722112-2017-00404; pancreatitis (b)(4)/mdr number: 3006722112-2017-00395; death (b)(4)/mdr number: 3006722112-2017-00401; obstruction (b)(4)/mdr number: 3006722112-2017-00411; obstruction(b)(4)/mdr number: 3006722112-2017-00412; obstruction (b)(4)/mdr number: 3006722112-2017-00415; obstruction (b)(4)/mdr number: 3006722112-2018-00004; death (b)(4)/mdr number: 3006722112-2018-00017; obstruction (b)(4)/mdr number: 3006722112-2018-00013; sepsis (b)(4)/mdr number: 3006722112-2018-00049; obstruction (b)(4)/mdr number: 3006722112-2018-00062; pancreatitis (b)(4)/mdr number: 3006722112-2018-00090; pulmonary embolism, pancreatitis, inflammation of gallbladder or cholecystitis, gastric obstruction, sepsis, and/or death.9.Please provide all relevant information which your firm used to determine that the reported events of pulmonary embolism, pancreatitis, inflammation of gallbladder or cholecystitis, gastric obstruction, sepsis, death, and dialysis is occurring with a greater or lesser frequency and/or severity, than is stated in the labeling for the device, or expected (i.E.Where the device labeling is silent on the event frequency and severity).In your response, please provide the expected and observed frequency and severity for the reported event with this device and, as applicable, the family it belongs to.Response: apollo calculated the observed rate of pulmonary embolism, pancreatitis, inflammation of gallbladder or cholecystitis, obstruction, sepsis, and death worldwide from 01/jan/2008 through 16/mar/2018 using the number of complaints divided by sales.The observed rate for each event is as follows; pulmonary embolism (<0.001%), pancreatitis (0.005%), inflammation of gallbladder or cholecystitis (<0.001%), obstruction (0.034%), sepsis (0.001%, death (0.008%).The expected rates, as listed in the labeling, are as follows; pancreatitis (<0.01%), obstruction (0.04%), death (0.01%).Pulmonary embolism is captured in the labeling under "cardiopulmonary complication and dyspnea," which has an expected rate of (<0.01%), inflammation of gallbladder or cholecystitis is captured in the labeling under "other," which has an expected rate of (0.16%), and sepsis is captured in the labeling under "infection," which has an expected rate of (0.02%)the observed rates are consistent with the expected rates as provided in the labeling.Dialysis is not included as we feel this is considered treatment and not a complaint.10.Describe how users are expected to mitigate the reported device difficult to remove issue.What are your trainings for physicians regarding when to remove the device? response: apollo endosurgery trains physicians on different patient types (early intolerant, delayed intolerant, mild refractory delayed intolerance), including patient management steps to take for each patient type.Physicians are told to remove the balloon if symptoms persist or return early (refractory intolerance) after various treatment steps such as returning to liquid diet, changing antiemetics and/or ppis, adding prokinetics, ng decompression, etc.For a delayed intolerant patient, physicians are told to consider intubation for balloon removal.Physicians are also informed to remove the device in cases of: pregnancy confirmed during treatment, patient undergoing surgery, refractory intolerance with x-ray findings of distended stomach and antral balloon, balloon deflation, obstruction, gastric perforation, pancreatitis, possibly for spontaneous inflation if intolerance symptoms are present.Mitigation would include orbera directions for use; 10.2 orbera® removal (step-by-step) 1.Insure that the patient has been npo for a minimum of 12 hours prior to attempted removal.If removal is emergent and conditions don't allow for 12 hours of npo status prior to removal, then the airway should be secured and general anesthesia employed.2.Prepare the patient according to hospital protocol for sedation and endoscopy.3.Insert the endoscope into the patient's stomach.4.Assess for presence of food.If food is present in the stomach the procedure should be delayed.If emergent removal, the airway should be protected prior to proceeding.5.Get a clear view of the filled balloon through the endoscope.6.Insert a needle instrument down the working channel of the endoscope.7.Use the needle instrument to puncture the balloon.8.Push distal end of suction tubing through the balloon shell.9.Remove the needle from the tubing sleeve.10.Apply suction to the tube until all fluid is evacuated from the balloon.11.Remove the suction tubing from the balloon and out of the working channel of the endoscope.12.Insert a 2-pronged wire grasper through the working channel of the endoscope.13.Grab the balloon with the 2-pronger wire grasper (ideally at the opposite end of valve if possible).14.Consider administering an antispasmodic drug, such as hyoscine, to relax esophageal muscles for when the balloon is extracted through the neck region.15.With a firm grasp on the balloon, slowly extract the balloon up the esophagus.16.When the balloon reaches the throat, hyperextend the head to allow for a more gradual curve and easier extraction.17.Remove the balloon from the mouth.11.Please provide the results of risk management activities completed by your firm which address the reported device problem.Indicate the frequency and severity of the hazard, cause(s), and the applicable control(s) implemented to mitigate the hazard.Response: apollo addresses risks to health by assessing failure modes that may result from the design, the clinical application, and manufacturing per apollo endosurgery's internal risk management process procedure sop-0004-00.Thresholds for occurrence of each identified risk are closely monitored through regular systematic reviews of complaints, manufacturing issues, and literature to ensure pre-defined thresholds are not exceeded and that existing controls are functioning properly.The frequency of the reported events remains consistent within the respective classification groups, as noted in question 9 above.There has be no substantial increase in trending to trigger additional risk investigation.The reported events are addressed in the labeling, therefore apollo is taking no further action at this time.These types of complaints will continue to be closely monitored and reviewed.12.What actions has your firm taken to address this problem? response: apollo endosurgery is in the process of updating the physician dfu, physician training, patient dfu, and patient isi, surrounding the risks of perforation which may mitigate deaths suggested to be related to gastric perforation.Apollo and fda have agreed upon april 30th, 2018 as the target date for submission of these additions.Apollo endosurgery last updated the physician dfu and physician training to include acute pancreatitis and spontaneous inflation in june 2017.
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