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Medwatch sent to fda on 05/19/2017.This event was reported by the patient's child.To date, apollo has been unable to confirm the reported events with the patient's physician.The patient' child at the times of follow up did not have any physician information or additional patient information.An autopsy was not available, apollo's approach to compliance is to resolve all doubt in favor of reporting.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.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: death due to complications related to intestinal obstruction is possible.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.Death due to complications related to gastric or esophageal perforation is possible.Warnings: patients must be advised that orbera is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of balloon placement increase the risk of balloon deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when balloons are inflated to larger volumes (greater than 700cc).
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Apollo endosurgery received a letter of request from fda dated may 26, 2017 for additional information regarding mdr report number 3006722112-2017-00148.(b)(4).Response to fda request: please provide the disposition of the device, including information on your efforts to acquire or have the device returned for investigation.For reusable devices, indicate whether the device is still in use.Response: the disposition of the device is unknown.An apollo safety nurse made requests for additional information from the reporter on 20/apr/2017 and 25/apr/2017.No additional information has been received.The orbera balloon is a single use device, therefore the device is no longer in use.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.Response: apollo has been unable to gather information on the device catalog, serial or lot number.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 orbera balloon was placed on (b)(6) 2017.The patient passed away on (b)(6) 2017.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: at this time, the event remains unconfirmed with a healthcare professional.A copy of the autopsy has been requested, but has not been received at this time.Please provide a more complete description of this event including any relevant details surrounding the event.Response: at this time, limited information has been received from the reporter beyond the initial report.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device report are or not attributable to the device.Response: beyond the initial report by the patient's daughter, there is insufficient information relevant to further investigation or this reported event.Apollo's approach to compliance is to resolve all doubts in favor of reporting, and assume the events as reported are due to the device.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: response: the results of this investigation are inconclusive.An explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual.The device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received, including a copy of the autopsy report.A device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.A complete description of the investigation and analysis methodology(ies) used, neither device analysis, nor review of manufacturing records was possible for this case, as the device was not returned and the device id information is not known.The investigation included interviews with the reporter (the patient's daughter).A review of apollo's device labeling for this reported event was performed.The current international orbera intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of death, nausea, vomiting, and cardiac complications as follows: "warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes (greater than 700 cc)." "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, 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 orbera system include: - death due to complications related to intestinal obstruction is possible.- 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." "complications of routine endoscopy include: -adverse reaction to sedation or local anesthetic.- cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems)." an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and as apollo cannot determine if or how the event was device related based on limited communication provided from the reporter, it is not possible to determine if or how a specific failure mode could have contributed to this event.Any conclusions reached based on the investigation and analysis results.Assessment of the device involved in this complaint was not possible as the device was not returned and no serial/lot number was provided.It has not been possible to determine a root cause for the reported event.The events of death, nausea, vomiting, and cardiac complications are known and labeled possible adverse events.This type of complaint will continue to be monitored.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same death problem/issue.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 was unable to determine the root cause of the event, as the device was not returned for analysis, and therefore the specific device problem for this complaint is unknown.For that reason, apollo is unable at this time to determine how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that our firm has received in the past 2 years that are related to this same reported device problem (interpreted as root cause for device failure).However, apollo has submitted the below mdrs from june 1, 2015 to june 1, 2017 for the reported event of "death": (b)(4) mdr report number: 3006722112-2016-00034, (b)(4) mdr report number: 3006722112-2016-00108, (b)(4) mdr report number: 3006722112-2016-00150, (b)(4) mdr report number: 3006722112-2016-00338, (b)(4) mdr report number: 3006722112-2017-00148.Please provide more complete patient information related to this event such as age, gender, medical history, relevant laboratory test results, patient's signs and symptoms, and/or patient outcome.Response: apollo has been unable to gather additional information beyond the initial report.The patient was a female who was (b)(6) at the time of passing.As per the initial report, the day after the balloon was placed in (b)(6), the "family observed the patient collapse, no pulse, heart stopped, daughter performed cpr, pulse returned.The patient was taken back to hospital, given one bag iv fluids, doctors did not believe the patient's heart had stopped, not admitted.The patient and family flew back to the united states later that same day and went immediately to the hospital.The patient was admitted to the hospital on (b)(6) 2017.Multiple tests (ct scan of head and abdomen, ekg and ct angiogram) all normal, except a new finding of a left bundle branch blockage, the doctors were not concerned with the new finding.Discharged the patient home on thursday (b)(6) 2017, she died that afternoon.An autopsy is being performed, won't be available for 6-8 weeks.The copy of the autopsy report has not been received by apollo.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 described in the autopsy report.Please include the information source used in your response.Response: at this time, no additional information beyond the initial report has been received.A copy of the autopsy report has not been provided by the reporter, nor has any follow up information been received.The primary and secondary cause of death has not been reported to apollo by the patient's physician.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: as apollo has received limited information on the exact nature of the complaint, not received a copy of the post-mortem report, or obtained specific device identification, no review of risk documentation related to frequency, and severity can be completed.There have been several cases of unanticipated deaths cause unknown in orbera intragastric balloon patients since 2016.Currently, death is embedded in your labeling at page 26 out of 35-page labeling and not listed in the adverse events section.What actions will your firm take to address this problem? response: the us orbera directions for use addresses the event of death as follows: "warnings: patients must be advised that orbera® is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of balloon placement increase the risk of balloon deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when balloons are inflated to larger volumes (greater than 700 cc)." (page 6 of the dfu)."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." (page 7 of the dfu)."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." (page 7 of the dfu)."possible complications: possible complications of the use of orbera include: -death due to complications related to intestinal obstruction is possible." (page 9 of the dfu) -death due to complications related to gastric or esophageal perforation is possible.(page 10 of the dfu)."serious adverse events observed in global product experience with orbera and from literature reviews, but not seen in the u.S.Clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death." (page 10 of the dfu).Apollo has no plans for further action at this time.
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