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The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported events 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.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: injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding and perforation, which could require a surgical correction for control.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.Abdominal or back pain, either steady or cyclic.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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Apollo endosurgery received a letter of request from the fda dated march 1, 2018 for additional information regarding voluntary mw 5075065 - uf (b)(4)- mdr report number 3006722112-2018-00013.(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: apollo called the implanting physician's staff on (b)(6) 2018 to ask if the device was available to be returned for device analysis.Office staff replied they had no information regarding device availability.Apollo then called the risk manager at the treating facility on (b)(6) 2018 to ask if the device was available for return.The risk manager indicated that the device was available at the time of removal, however they need to verify if the device is still available for return.The risk manager indicated they would contact apollo if/when additional information is obtained.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: it was reported the device was placed on (b)(6) 2018 and removed on (b)(6) 2018.On (b)(6) 2018, the patient presented with abdominal pain, septic shock, and gastric perforation with free fluid in the abdomen and stomach necrosis.The primary event causing device removal was not specified.Please provide a more complete description of this event including any relevant details surrounding the event.Response: a company representative reported on behalf of the health care provider's office, a patient had "device placed without any issues on a thursday and over the weekend the patient presented with necrosis and stomach perforation.Patient developed intolerance symptoms with nausea, vomiting, abdominal discomfort for which modifications of the anti-emetic regimen were made.Several days later, the patient's spouse called physician with news of an acute deterioration of the patient's condition.Hours elapsed from the onset of the acute symptoms.The patient underwent an emergency laparoscopy with the findings of abdominal contamination from gastric contents and an antral perforation.A drain was placed and an exclusion temporizing maneuver was performed.The patient then underwent a second operation which involved an antrectomy." apollo's chief medical officer contacted the implanting physician to obtain additional information.The implanting physician stated they were not involved in the acute care of the patient, thus, had minimal information.It was reported the surgeries were done at another facility and [implanting physician] has not been successful in getting through to the surgeon, only the icu team.[implanting physician] did state that the patient had not had any prior gastric surgery.The patient had an uneventful balloon placement and did well."several days" later the patient developed intolerance symptoms with nausea, vomiting, and abdominal discomfort for which modifications of the anti-emetic regimen were made."several days "after that, the patient's spouse called with news of an acute deterioration in [patient's] condition.Hours elapsed from the onset of the acute symptoms.The patient underwent an emergency laparoscopy with the findings of abdominal contamination from gastric contents and an antral perforation.A drain was placed and an exclusion temporizing maneuver was performed.The patient then underwent a second operation [(b)(6) 2018] which involved an antrectomy.The implanting physician was unable to provide any additional detail.Additional information was received via voluntary medwatch report mw5075065 submitted by the treating/explanting physician, which stated, "patient underwent placement of intragastric balloon for weight loss, complicated by gastric perforation 1-2 post procedurally.The complication resulted in prolonged hospitalization and death directly attributable to the stated injury.This report is being submitted based on device-related concerns as described in the (b)(6) 2017 fda memo linked below: "update: potential risks with liquid-filled intragastric balloons - letter to health care providers." additional information was received via medwatch report (b)(6) from the treating/explanting facility's risk manager, which stated, "the patient had the intragastric balloon placed on (b)(6) 2018.[patient] presented to a community hospital on (b)(6) 2018 after feeling a 'popping' sensation in [their] abdomen overnight, with progressive abdominal pain the next day.[patient] was transferred to our facility on (b)(6) 2018.On admission [patient] was in septic shock and had suffered a large posterior gastric perforation with free fluid in the abdomen.The balloon was intact.Our surgical team performed a subtotal gastrectomy as [patient] had significant necrosis of the entire posterior wall of [their] stomach.[patient] was subsequently re-operated on 4 additional times ((b)(6)) to control [their] infection and was left with [their] esophagus and duodenum in discontinuity.Reconstruction could not be attempted at this time.[patient] eventually recovered from [their] sepsis but could not be weaned off mechanical ventilation.On (b)(6) 2018, the patient once again went into septic shock with likely another abdominal catastrophe.[patient] was transitioned to comfort care and died on (b)(6) 2018.[patient's] underlying cause of death is catastrophic gastric perforation." 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 contacted the implanting physician to obtain additional information.The implanting physician stated they were not involved in the acute care of the patient, thus, had minimal information.It was reported the surgeries were done at another facility and [implanting physician] has not been successful in getting through to the surgeon, only the icu team.[implanting physician] did state that the patient had not had any prior gastric surgery.The patient had an uneventful balloon placement and did well."several days" later the patient developed intolerance symptoms with nausea, vomiting, and abdominal discomfort for which modifications of the anti-emetic regimen were made."several days "after that, the patient's spouse called with news of an acute deterioration in [patient's] condition.Hours elapsed from the onset of the acute symptoms.The patient underwent an emergency laparoscopy with the findings of abdominal contamination from gastric contents and an antral perforation.A drain was placed and an exclusion temporizing maneuver was performed.The patient then underwent a second operation today which involved an antrectomy.The implanting physician was unable to provide any additional detail.Additional information was received via voluntary medwatch report mw5075065 submitted by the treating/explanting physician, which stated, "patient underwent placement of intragastric balloon for weight loss, complicated by gastric perforation 1-2 post procedurally.The complication resulted in prolonged hospitalization and death directly attributable to the stated injury.This report is being submitted based on device-related concerns as described in the (b)(6) 2017 fda memo linked below: "update: potential risks with liquid-filled intragastric balloons - letter to health care providers." additional information was received via medwatch report (b)(6) from the treating/explanting facility's risk manager, which stated, "the patient had the intragastric balloon placed on (b)(6) 2018.[patient] presented to a community hospital on (b)(6) 2018 after feeling a 'popping' sensation in [their] abdomen overnight, with progressive abdominal pain the next day.[patient] was transferred to our facility on (b)(6) 2018.On admission [patient] was in septic shock and had suffered a large posterior gastric perforation with free fluid in the abdomen.The balloon was intact.Our surgical team performed a subtotal gastrectomy as [patient] had significant necrosis of the entire posterior wall of [their] stomach.[patient] was subsequently re-operated on 4 additional times ((b)(6)) to control [their] infection and was left with [their] esophagus and duodenum in discontinuity.Reconstruction could not be attempted at this time.[patient] eventually recovered from [their] sepsis but could not be weaned off mechanical ventilation.On (b)(6) 2018, the patient once again went into septic shock with likely another abdominal catastrophe.[patient] was transitioned to comfort care and died on (b)(6) 2018.[patient's] underlying cause of death is catastrophic gastric perforation." 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 treating/explanting physician reported, "patient underwent placement of intragastric balloon for weight loss, complicated by gastric perforation 1-2 post procedurally.The complication resulted in prolonged hospitalization and death directly attributable to the stated injury." the risk manager from the treating/explanting facility reported, "[patient's] underlying cause of death is catastrophic gastric perforation." please provide a complete list of medical device reports (mdrs) that you have determined are related to problem/issues of death, perforation, sepsis or septic shock, and mechanical ventilation.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 as received in the past 2 years that are related to this same reported device problems.Response: please see the complete list of medical device reports (mdrs) that have been reported for problems/issues of death, perforation, sepsis and/or septic shock from pma approval.Mechanical ventilation was not considered as we feel this is considered treatment and not a complaint.Apollo has received a total of 20 complaints from 01/mar/2016 through 16/mar/2018 related to death, perforation, sepsis and/or septic shock.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00034; death.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00108; death.Mfr ref number:(b)(4)/mdr number: 3006722112-2016-00096; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00150; death, stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00151; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00293; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00347; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00346; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2016-00338; death.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00018; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00084; sepsis.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00148; death.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00169; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00347; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00350; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00349; stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2017-00395; death, stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2018-00004; death, stomach perforation.Mfr ref number: (b)(4)/mdr number: 3006722112-2018-00013; death, stomach perforation.Please provide all relevant information which your firm used to determine that the reported events death, perforation, sepsis or septic shock, and mechanical ventilation 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 death, stomach perforation, and sepsis and/or septic shock worldwide from (b)(6) 2008 through (b)(6) 2018 using the number of complaints divided by sales.The observed rate for each event is as follows; death ((b)(4)), stomach perforation ((b)(4)), and sepsis and/or septic shock ((b)(4)).The expected rates, as listed in the labeling, are as follows; death ((b)(4)), stomach perforation ((b)(4)).Sepsis and/or septic shock is captured under infection in the labeling, which lists a rate of ((b)(4)).Gastric perforation with sepsis was reported in the (b)(6) study in 1 out of 160 patients ((b)(4)).The observed rates are consistent with the expected rates as provided in the labeling.Mechanical ventilation was not considered as we feel this is considered treatment and not a complaint.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: the root cause of the occurrences remains inconclusive.The treating/explanting physician reported, "patient underwent placement of intragastric balloon for weight loss, complicated by gastric perforation 1-2 post procedurally.The complication resulted in prolonged hospitalization and death directly attributable to the stated injury." the risk manager from the treating/explanting facility reported, "[patient's] underlying cause of death is catastrophic gastric perforation." b.Complete description of investigation and analysis methodology(ies) used, response: a company representative reported on behalf of the health care provider's office, a patient had "device placed without any issues on a thursday and over the weekend the patient presented with necrosis and stomach perforation.Patient developed intolerance symptoms with nausea, vomiting, abdominal discomfort for which modifications of the anti-emetic regimen were made.Several days later, the patient's spouse called physician with news of an acute deterioration of the patient's condition.Hours elapsed from the onset of the acute symptoms.The patient underwent an emergency laparoscopy with the findings of abdominal contamination from gastric contents and an antral perforation.A drain was placed and an exclusion temporizing maneuver was performed.The patient then underwent a second operation which involved an antrectomy." apollo's chief medical officer contacted the implanting physician to obtain additional information.The implanting physician stated they were not involved in the acute care of the patient, thus, had minimal information.It was reported the surgeries were done at another facility and [implanting physician] has not been successful in getting through to the surgeon, only the icu team.[implanting physician] did state that the patient had not had any prior gastric surgery.The patient had an uneventful balloon placement and did well."several days" later the patient developed intolerance symptoms with nausea, vomiting, and abdominal discomfort for which modifications of the anti-emetic regimen were made."several days "after that, the patient's spouse called with news of an acute deterioration in [patient's] condition.Hours elapsed from the onset of the acute symptoms.The patient underwent an emergency laparoscopy with the findings of abdominal contamination from gastric contents and an antral perforation.A drain was placed and an exclusion temporizing maneuver was performed.The patient then underwent a second operation today which involved an antrectomy.The implanting physician was unable to provide any additional detail.Additional information was received via voluntary medwatch report mw5075065 submitted by the treating/explanting physician, which stated, "patient underwent placement of intragastric balloon for weight loss, complicated by gastric perforation 1-2 post procedurally.The complication resulted in prolonged hospitalization and death directly attributable to the stated injury.This report is being submitted based on device-related concerns as described in the (b)(6) 2017 fda memo linked below: "update: potential risks with liquid-filled intragastric balloons - letter to health care providers." additional information was received via medwatch report (b)(4) from the treating/explanting facility's risk manager, which stated, "the patient had the intragastric balloon placed on (b)(6) 2018.[patient] presented to a community hospital on (b)(6) 2018 after feeling a 'popping' sensation in [their] abdomen overnight, with progressive abdominal pain the next day.[patient] was transferred to our facility on (b)(6) 2018.On admission [patient] was in septic shock and had suffered a large posterior gastric perforation with free fluid in the abdomen.The balloon was intact.Our surgical team performed a subtotal gastrectomy as [patient] had significant necrosis of the entire posterior wall of [their] stomach.[patient] was subsequently re-operated on 4 additional times ((b)(6)) to control [their] infection and was left with [their] esophagus and duodenum in discontinuity.Reconstruction could not be attempted at this time.[patient] eventually recovered from [their] sepsis but could not be weaned off mechanical ventilation.On (b)(6) 2018, the patient once again went into septic shock with likely another abdominal catastrophe.[patient] was transitioned to comfort care and died on (b)(6) 2018.[patient's] underlying cause of death is catastrophic gastric perforation." the health care provider's office could not provide any information regarding if the device is available for return.C.An identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and response: specific failure modes for the reported events could not be identified at this time.As noted, the healthcare provider's office could not provide any information regarding if the device is available for return.D.Any conclusions reached based on the investigation and analysis results.Response: the root cause for these events remain inconclusive.The user effects of "necrosis", "stomach perforation / erosion", "nausea", "vomiting", "pain", "other - abdominal contamination" and "esophageal perforation" and "death" are known and labeled possible adverse events.This type of complaint will continue to be monitored as appropriate.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.A device history record review is not possible for this complaint as the device lot and serial number are unknown.The health care provider's office could not provide any information regarding if the device is available for return.Please identify the exact location in the labeling where users are warned of steps to take to prevent the death, perforation, sepsis or septic shock, and mechanical ventilation from occurring.How users are expected to mitigate these problems should it occur.Response: please see the locations where users are warned of death and perforation.Sepsis and/or septic shock is not specifically discussed; however, it is mentioned that gastric perforation with sepsis was reported in the (b)(6) study in 1 out of 160 patients ((b)(4)).The observed rates are consistent with the expected rates as provided in the labeling.Mechanical ventilation was not considered as we feel this is considered treatment and not a complaint.Death: warnings, bullet point 1 (page 6): 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).Warnings, bullet point 5 (page 7): 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.Warnings, bullet point 6 (page 7): 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 possible complications, bullet points 1 and 2 (page 9): possible complications include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel, as may occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Death due to complications related to intestinal obstruction is possible.Possible complications, bullet point 17 (page 10): death due to complications related to gastric or esophageal perforation is possible.Filling recommendations, (page 27-28): filling should always be completed under direct visualization (gastroscopy).Integrity of the valve should be confirmed by observing the valve lumen as the balloon fill tube is removed from the valve.A balloon with a leaking valve must be removed immediately.A partially inflated, or deflated balloon can result in a bowel obstruction, which can result in death.Bowel obstructions have occurred as a result of unrecognized or untreated balloon deflation.Perforation: possible complications, bullet point 5 (page 9): injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding and perforation, which could require a surgical correction for control.Possible complications, bullet point 16, (page 10): 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.Filling recommendations, (page 26): the expandable design of the orbera® permits a fill volume range of 400cc (minimum) to a maximum of 700cc.The orbera® should not be under-filled or over-filled with volumes <400 cc or >700 cc, as under- or over-filling the balloon could cause higher risk for serious side effects, such as migration (under-filled balloon) or gastric rupture/perforation (over-filled balloon).Once filled, orbera® is not adjustable.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 (b)(4).Thresholds for occurrence of each identified risk is 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 seen in question 7.There has be no substantial increase in trending to trigger additional risk investigation.The reported events are currently addressed in the labeling, however, 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 as the target date for submission of these additions.These types of complaints will continue to be closely monitored and reviewed.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 as the target date for submission of these additions.
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