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Apollo endosurgery received a letter of request from fda dated february 23, 2017 for additional information regarding mdr report number 3006722112-2016-00338.(b)(6).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 21/oct/2016, 23/oct/2016, and 27/oct/2016, including inquiries into if the device is available for return and analysis.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: the device listed in this medical device report is an orbera intragastric balloon, catalog number b-50000.Apollo has been unable to gather the device 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) 2016.The exact duration from implant date to the patient's passing is unknown.Please describe any design change(s) or modification(s) to the device, since the device was initially introduced into the market that may be related to the event.Please also include the date(s) the design change(s) or modification(s) occurred.Response: not applicable - there have been no design changes or modifications to the device since it was introduced to the us market.Please provide the total number of devices manufactured, distributed, and if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside of the us.Response: currently, apollo does not track the number of devices used per year, therefore this information is not available.Total sales of devices plus units manufactured (not including accessories) are listed below: total orbera units sold/distributed u.S.01apr2014 to 01apr2017: (b)(4).Total orbera units sold/distributed outside of the u.S.01apr2014 to 01apr2017; (b)(4).Total orbera units manufactured 01apr2014 to 01apr2017 (b-4800, b-40800 and b-50000): (b)(4) units.Please provide any evaluation of the event described in the medical device report by the attending physician, surgeon, hospital representative or healthcare professional.Response: the reporter, the patient's implanting physician, stated: "a patient who had the orbera intragastric balloon was placed with their second consecutive balloon and was filled with 600 ml, the previous balloon was filled to 500 ml.The physician noted that there were no contra indications that he was aware of and the patient had been successful at attaining a 28 kgs weight loss.Three days after placement the patient was taken to the hospital "when family insisted that [the patient] was vomiting more than expected and they were concerned.[patient] was taken to intensive care and also given a ct scan that confirmed the balloon was still fully inflated and at some point in the icu he was fitted with an ng tube.His sodium and potassium levels were "normal." [the patient] was on proton-pump inhibitors (ppis) for the orbera." the patient passed away, the cause of death is currently "unknown".A copy of the post-mortem report was requested, however has not been received.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 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 post-mortem 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 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 implanting physician.A review of apollo's device labeling for this reported event was performed.The current orbera intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of death and vomiting as follows: "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." "if it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation." "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." 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 the 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 death and vomiting 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 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 april 1, 2015 to april 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.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 male of an unspecified age, with medical history and relevant laboratory tests (if any) not provided by the reporter.The patient presented to the hospital three days after his second consecutive balloon placement due to excessive vomiting.The patient then passed away at an unspecified date; a copy of the post-mortem report was requested, however 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 device record, or as it is 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 post-mortem report has not been provided by the reporter, nor has any follow up information been received.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, 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.
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