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The reporter of the event was asked to return the product for analysis.They indicated that the device was discarded.Further information has been requested of the initial reporter regarding: the device serial number.To date, no additional information has been received by apollo.Device labeling addresses the reported events as follows: precautions: 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.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: - 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.Potential risks associated with upper endoscopic procedures include, but are not limited to:abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed.(b)(6) clinical study: safety events were as expected for the orbera¿ group, with the majority of the orbera¿ group reporting gastrointestinal adverse events during the first two weeks after placement.The most common device-related adverse events were nausea and vomiting (74.2%), abdominal pain (54.8%), gastroesophageal reflux (38.7%), lethargy (32.3%), and dehydration (25.8%).These events typically resolved within two weeks.Two subjects experienced 7 serious adverse events which led to removal prior to 6 months.Serious adverse events included: gastroesophageal reflux, vomiting, nausea, and abdominal pain.There were no deaths or unanticipated adverse device effects.The event of hiccups was reported in the us pivotal clinical study and was experienced by 2.5% of the participants.
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Apollo endosurgery received a letter of request from fda dated may 26, 2017 for additional information regarding mdr report number 3006722112-2017-00106.(b)(6).Response to fda request: 1.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: after contacting the placement/treating physician's office, they indicted the device was discarded after removal, and will not be returned for analysis.The orbera balloon is a single use device, therefore the device is no longer in use.2.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: the device listed in this medical device report is an orbera intragastric balloon, catalog number b-4800.The reporter has been unable to provide the device serial or lot number.3.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 and removed on (b)(6) 2017.The patient had "been vomiting every day and has a tight hard stomach." the patient went to the hospital and was "very dehydrated, creatinine is high, renal failure, potassium 3.1, x-ray performed and a ng tube was placed which helped to stop the hiccups." the patient was admitted to the hospital overnight.The physician believes the patient has gastroparesis.This was the patient's second device.The physician decided to remove the device to hasten the resolution of symptoms.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: the treating physician reported that the spouse of the patient had contacted them several days post placement, stating the patient couldn't keep anything down, had been vomiting every day and had a tight hard stomach.The patient's spouse called 911, and an ambulance picked them up.The treating physician reported the patient was seen at the hospital, "very dehydrated, creatinine is high, renal failure, potassium 3.1." an x-ray performed and a ng tube was placed which helped to stop the hiccups.The patient was then transferred to the hospital and admitted under the treating physician.This was the patient's second balloon, placed 3 months after removal of the first.The treating physician then reported further information after seeing the patient; creatinine down to normal, x-ray shows balloon is perfectly positioned, ng tube removed 3 liters of fluid, patient will be staying overnight at the hospital.The physician reported that they pulled the ng once, and the patient had hiccups and vomiting so the ng was placed again, removing an additional 1 liter of fluid.The treating physician believes the patient has gastroparesis.The patient was given iv potassium, still low potassium 3.5.Starting clamping ng tube no residuals overnight so he believes the patient has started stomach contractions.The treating physician then reported: the "patient had a 625 cc on the first balloon; 650 cc on this one, very large capacity stomach, 2 liters out on the first day, on both reglan plus e-mucin, 4 hour clamp with return of nausea and vomiting, potassium just at 3.5 with 4 piggy back k supplements.[they] are going to remove the balloon".5.Please provide a more complete description of this event including any relevant details surrounding the event.Response: no additional information beyond the initial report from the treating physician has been received.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: this event was reported by the patient's implanting/treating physician, and all events all are assumed to be device related.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.7.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.(1) an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual.The device will not be returned for analysis.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.(2) 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 treating physician.A review of apollo's device labeling for this reported event was performed.The current orbera intragastric balloon system directions for use (dfu) and orbera patient planner address the known and anticipated potential events of vomiting, dehydration, gastroparesis, hiccups and renal failure as follows: "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 apollo device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual orbera beyond 6 months." "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.- a feeling of heaviness in the abdomen."potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed." "the event of dehydration was reported in the us pivotal study and was experienced by 14.4% of the participants" "the event of hiccups was reported in the us pivotal clinical study and was experienced by 2.5% of the participants." "the event of impaired gastric emptying was reported in the us pivotal clinical study and was experienced by 8.8% of the participants." also noted in the orbera patient planner: "tell your doctor if you cannot keep liquids down and cannot swallow, or if you are nauseated or throwing up.You could become dehydrated and your kidneys could shut down." (3) an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and as the device will not be returned for analysis, apollo cannot determine if or how a specific failure mode could have contributed to this event.(4) any conclusions reached based on the investigation and analysis results.Assessment of the device involved in this complaint was not possible.It has not been possible to determine a root cause for the reported event.The events of vomiting, dehydration, gastroparesis, hiccups and renal failure are known and labeled possible adverse events.This type of complaint will continue to be monitored.8.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same gastroparesis or renal failure 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 july 1, 2015 to june 30, 2017 for the reported events of "gastroparesis" and "renal failure": gastroparesis: (b)(4) mdr report number: 3006722112-2015-00594, (b)(4) mdr report number: 3006722112-2016-00064, (b)(4) mdr report number: 3006722112-2016-00087, (b)(4) mdr report number: 3006722112-2016-00111, (b)(4) mdr report number: 3006722112-2016-00257, (b)(4) mdr report number: 3006722112-2016-00260, (b)(4) mdr report number: 3006722112-2016-00319, (b)(4) mdr report number: 3006722112-2016-00385, (b)(4) mdr report number: 3006722112-2017-00094, (b)(4) mdr report number: 3006722112-2017-00076, (b)(4) mdr report number: 3006722112-2017-00106, (b)(4) mdr report number: 3006722112-2017-00131, (b)(4) mdr report number: 3006722112-2017-00153.Renal failure: (b)(4) mdr report number: 3006722112-2016-00337, (b)(4) mdr report number: 3006722112-2016-00359, (b)(4) mdr report number: 3006722112-2017-00106.9.Please identify the exact location in the labeling where users are warned of steps to take to prevent the gastroparesis or renal failure from occurring, and/or how to mitigate the problem should it occur.Response: users are advised in the current orbera intragastric balloon system directions for use (dfu): "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." (page 8 of the dfu) "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." (pages 7 and 8 of the dfu)."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." (page 9).Noted in the current orbera patient planner: "tell your doctor if you cannot keep liquids down and cannot swallow, or if you are nauseated or throwing up.You could become dehydrated and your kidneys could shut down." and, "tell your doctor right away if you feel nonstop nausea, or if you cannot stop throwing up.Tell your doctor right away if you have stomach cramps that are so bad that you cannot drink any liquids.If you do not tell your doctor about your nausea or vomiting, your body could lose too much water and salts.You may need to go to the hospital to make sure you do not develop problems with your heart and kidneys.Your doctor may give you medicine to take, replace fluids through your vein, or may even have to remove your orbera." 10.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: the patient was a male of an unspecified age, with medical history (if any) not provided by the treating physician.The patient presented to the hospital shortly after placement of his second balloon due to excessive vomiting.The patient was noted to have dehydration, renal failure and hiccups.An x-ray was performed, and an ng tube was placed to help stop the hiccups.The patient was then transferred to a different hospital, and admitted under the placement physician.The placement/treating physician after seeing the patient noted: creatinine down to normal, x-ray shows balloon is perfectly positioned, ng tube removed 3 liters of fluid, patient will be staying overnight at the hospital.Further information provided from the doctor said he pulled the ng once and he had hiccups and vomiting so the ng was placed again removing an additional 1 liter of fluid.He believes the patient has gastroparesis.The patient was given iv potassium still low potassium 3.5.Starting clamping ng tube no residuals overnight so he believes the patient has started stomach contractions.The balloon was removed.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: the event of impaired gastric emptying was reported in the us pivotal clinical study and was experienced by 8.8% (14) of the subjects, occurring at a frequency of 1.7%.The event of renal failure was not experienced by any patients within the us pivotal study.12.What actions has your firm taken to address this problem? response: these types of complaints will continue to be monitored, through quarterly complaints analysis meetings, management review and by annual risk review.Apollo plans to take no action at this time.
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