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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM

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APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
Model Number B-4800
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Fatigue (1849); Nausea (1970); Vomiting (2144)
Event Date 03/16/2016
Event Type  Death  
Manufacturer Narrative

Further information has been requested of the initial reporter, including patient history and if a copy of the autopsy report or any other lab tests are available. To date, no additional information has been received by apollo. Device labeling addresses the reported event 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. Complications of routine endoscopy include: cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems).

 
Event Description

A company representative received a notification from a physician reporting: a patient who had the orbera intragastric balloon placed: "was one month to the day post-placement of orbera device. The physician stated the patient had had no remarkable problems and was doing well prior to receiving the news that the patient had died. " the physician then provided additional information that the patient was "normal post placement; three days of nausea and a couple bouts of vomiting" along with feeling fatigued for a week after. The patient had been doing very well, back at work, no issues except a week prior to their death. They had called the doctor to report a hemorrhoid problem. The physician saw the patient the following day and found a hemorrhoid thrombosis and no other issue. No problem noted with the orbera. The physician stated that if an autopsy is performed they will provide the findings. No additional information has been received at this time.

 
Manufacturer Narrative

Medwatch sent to fda on 07/29/2016. Apollo endosurgery received a letter of request from the fda dated june 16, 2016 for additional information regarding mdr report number: 3006722112-2016-00108. 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. Response: the disposition of the device is unknown at this time. The placement physician was contacted by apollo medical affairs on 03/17/2016, 03/18/2016 and 4/13/2016, whom at each attempt had no new information from the patient's family to report beyond what was captured in the initial complaint, including whether or not the device was removed. Another attempt was made on 07/26/2016, requesting additional information, including the contact information of the patient's attending physician at the time of their death. No additional information has been reported. 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 event was reported by the patient's placement physician. The placing physician, after reporting the original event, called back to state that the patient was a nurse at the hospital where he performs procedures, and that the patient had "normal post placement 3 days of nausea and a couple bouts of vomiting" along with feeling fatigued for a week after. The placement physician reported that the patient had been doing "very well, back at work, no issues except a week prior to their death, on that sunday the patient had called the doctor to report a hemorrhoid problem. " the placement physician assessed the patient the following day and noted they had a hemorrhoid thrombosis, and no other issues were noted. The placement physician stated there was no problem with the orbera device. The placement physician in the initial report to apollo stated the patient's family was in contact with the hospital, and if an autopsy were to be performed, he would be able provide the findings to apollo. Since that communication, apollo has not received any updated information from the placement physician, has not received the results of an autopsy report, and attempts to contact the placement physician have not been successful. Please provide a more complete description of this event including any relevant details surrounding the event. Response: at this time, no additional information beyond the initial report has been received. Please provide all relevant information which your firm used to determine that the reported event is occurring with greater or lesser frequency and/or severity, than is stated in the labeling for the device. Response: apollo's approach to compliance is to resolve all doubts in favor of reporting. As there has been very limited information received regarding the nature of the patient's death, and what factor, if any, the device contributed, a frequency rate could not be calculated. 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: the initial interview with the patient's orbera placement/after care physician gave no indication of unanticipated device issues. Attempts to gather the patient's attending physician's contact information for further evaluation of the reported event have been unsuccessful, therefore no additional information about the possible presence of device issues is known. Please provide the results for any investigation, evaluation and/or failure analysis, including the 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 b. A complete description of the investigation and analysis methodology(ies) used, c. An identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and d. Any conclusions reached based on the investigation and analysis results. Response: the results of this investigation are inconclusive. (a) the device has not been returned for analysis, and after multiple attempts to gather more information from the placement physician, 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. (b) 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 placement/aftercare physician, and attempted interviews with the attending physician. A review of the labeling for this device as well as the complaint history for this reported event was performed. The current orbera intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event(s) of "death", "nausea" and "vomiting": "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. " "complications of routine endoscopy include: -cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems). " the labeling is adequate as it addresses the reported complaint. A review of similar orbera complaints received by apollo from april 1, 2016 to july 1, 2016 found no other instances of "death" reported. (c) as apollo cannot determine if or how the event was device related based on limited communication from the reporter, it is not possible to determine if or how a specific failure mode could have contributed to this event. (d) 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 nausea, vomiting and death are known and labeled possible adverse events. This type of complaint will continue to be monitored. Please provide more complete patient information related to this event such as age, gender, medical history, relevant laboratory results, patient's signs and symptoms, and/or patient outcome. Response: at this time, no additional information beyond the initial report has been received. 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 was 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, if available, was requested multiple times. No further information has been received from the patient's placement physician. No information has been received from the patient's attending physician at the time of death. 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: no specific device problem was reported nor was able to be identified. If and when additional information is received, this information will be reviewed against the risk documentation.

 
Manufacturer Narrative

Additional information: describe event or problem.

 
Event Description

Additional information: physician provided clarification regarding the event noting, "the patient was having problems with hemorrhoids, was on bedrest, and developed a fatal pulmonary embolism. " the event was unrelated to the balloon.

 
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Brand NameORBERA INTRAGASTRIC BALLOON SYSTEM
Type of DeviceINTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. captial of texas hwy
bldg 1, ste. 300
austin TX 78746
Manufacturer (Section G)
ALLERGAN
global park free zone
900 global park
la aurora de heredia,
CS
Manufacturer Contact
laura lebouef
1120 s. capital of texas hwy
bldg. 1, ste. 300
austin, TX 78746
5122795141
MDR Report Key5574835
MDR Text Key42585995
Report Number3006722112-2016-00108
Device Sequence Number1
Product Code LTI
Combination Product (Y/N)N
PMA/PMN NumberP140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberB-4800
Device Catalogue NumberB-4800
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/13/2016 Patient Sequence Number: 1
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