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

Model Number N/A

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis, and evaluation is in process by apollo.Device labeling addresses the reported event 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.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: possible complications of the use of orbera include: bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.

Event Description

Reported as: the patient had the orbera intragastric balloon system placed.The patient went back to see their physician and "it was identified by x-ray that the balloon had inflated about 1/3 with air." the device was removed, and at the time of removal "visual inspection confirmed 30-40% of the volume filled with air." the balloon was removed according to standard procedure without incident.The physician reported noticing on one side "a dark discoloration" on the inside of the removed device.Following removal, the physician inspected the patient's anatomy and determined that there was no issue preventing the placement of a second balloon.The second balloon was placed according to standard technique without incident.

Manufacturer Narrative

Device evaluation summary: a visual analysis performed on the returned device noted it was discolored, which appeared to be yellow and brown in color, with a darker discoloration on one side.A gel-like substance was observed on both the inner and outer surfaces of the device.The valve was noted to be reddish in color, and unidentified particles were observed in the valve.Two holes were noted on the surface of the device.Under microscopic analysis, three surgical damage-like openings on the shell were observed, consistent with damage from a removal tool.An air leak test was performed, and bubbles were observed coming from the three openings noted to be created by a removal tool.It was also noted the fill tip did not need to be fully inserted into the valve to inflate the device for testing, as the valve was open.The lab analyst then determined a valve test was not feasible, as the valve appeared to be damaged/open.Apollo endosurgery received a letter of request from fda dated january 4th, 2016 for additional information regarding mdr report number 3006722112-2015-00595.An extension was requested and granted by jian connell to extend the response date to march 18th, 2016.(b)(4).Response to fda request: we wish to clarify one discrepancy was observed in the letter from the agency to apollo.The letter dated january 4th, 2016 included an excerpt from the manufacturer report 300672212-2015-00595 that listed also the coded information.The patient problems code as well as the device problems code referenced in the agency's letter do not match the ones submitted by apollo for these fields in our initial medwatch.Please let us know if we need to take further action to clarify these report details, thank you.(b)(4).If the device did not function or perform as expected, please describe which device function or feature did not perform as intended, and the manner in which the device did not function as expected.Additionally, please discuss whether the unexpected function or behavior resulted in the event described.Response: the intended device behavior is to remain filled with sterile saline after the balloon is filled and placed within the stomach by a physician, until balloon removal by physician, without growing larger in size.The root cause of the event described is unknown.Describe the parts or components of the devices that led to the issue of air inflation.Provide a schematic of the reported device(s) and indicate where on the schematic the air inflation and discoloration of the device occurred.Response: the root cause of the inflation is unknown, therefore it is unknown what parts or components of the device led to the issue of inflation.The device was returned to apollo deflated.However mri images of the device in the stomach show the balloon shell portion of the device inflated (see attachment 1, red circle).Discoloration yellow and brown in color was found on one side of the shell of the balloon, and discoloration reddish in color was found on the valve (blue pointers).Please provide the device implant and explant dates, and/or the duration of the implant time.Response: implant date: unknown, explant date: (b)(6) 2015, duration of implant time: unknown.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, or expected (i.E.Where the device labeling is silent on 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 of devices it belongs to.Response: apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event.The apollo device labeling is silent on event frequency and severity.The apollo risk documentation for this product [the family of devices it belongs to, including apollo ous skus for this product] establishes the expectation for the frequency and severity of this reported event.Apollo experience: the reported event for this case resulted in clinical intervention for the patient to have the device removed.Apollo device risk documentation: the apollo risk documentation for this device establishes the severity ranking for this reported event as "serious", which is defined by apollo as "injury to user/patient is possible, with significant, temporary discomfort that may require clinical intervention or prescriptive medication to treat".Apollo experience: the rate of us inflation complaints over units sold in the same region from august through december 2015 = (b)(4).Apollo device risk documentation: the apollo risk documentation for this device establishes the occurrence ranking for this reported event as "remote", which is defined by apollo as (b)(4) of complaints over units sold.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual: response: follow-up with initial reporter (the patient) as well as the explanting physician resulted in the submission to apollo of images of the implanted device and mri scans of the implanted device within the patient's body.Follow up with the reporting facility to request return of the device resulted in the device being returned for device analysis, however root cause of the failure could not be determined through analysis of the returned device.In addition, follow up with the explanting provided to apollo the information that the hospital conducted their own analysis on the fluid extracted from the over-inflated balloon at the time of balloon removal.The explanting physician reported that the tests showed growth of candida glarbrata from the extracted fluid.A copy of this analysis report was not provided to apollo.Growth of this kind of fungus within the contained space of an implanted balloon could have led to the production of gaseous by-products, the introduction of which into the confined space of the implanted balloon could lead to balloon inflation.Although apollo was not able to verify the chemical makeup of the gaseous portion of the balloon contents at the time of balloon removal, the growth of candida glarbrata inside the implanted balloon is the probable cause for the inflation.Apollo is not able to determine at this time how the fungus candida glarbrata was introduced into the balloon.Therefore the root cause of this event is unknown at this time.A complete description of investigation and analysis methodology(ies) used: response: the methodology used for this investigation included a review of all reported information, interviews and follow up with the complainant, a labeling evaluation, a risk review for this event, and laboratory analysis of the returned device, as per apollo process.In addition, this investigation includes fluid analysis of the fluid removed from the explanted device performed by the reporting facility.An identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved: response: the exact root cause of the device inflation for this event is not known; the specific failure mode(s) and/or mechanism(s) could not be confirmed any conclusions reached based on the investigation and analysis results: response: the root cause of this event could not be determined, although the investigator was able to verify the device failure (inflation).Through video and images of the device at the time of balloon removal, the event was confirmed.Through supplemental fluid analysis testing performed by the treating institution, it is known that candida glarbrata growth was found in the fluid extracted from the balloon at the time of removal.Although fungal growth within the implanted balloon is a probable cause of the device failure "inflation", the cause of the presence of fungus inside the saline filled balloon after placement is unknown.Therefore the root cause of this event is unknown at this time.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: a complete list of medical device reports (mdrs) that we have determined are related to this same problem/issue is below.This list is generated as of december 31st, 2015.As of 31st december 2015, there were 7 mdrs in addition to the one for which this response is written have been filed for the issue of "inflation" of an intragastric balloon after the balloon is filled with saline and placed in the stomach.Mdr report number 9617229-2015-00342, 9617229-2015-00355, 9617229-2015-00368, 9617229-2015-00415, 3006722112-2016-00008, 3006722112-2015-00573, 3006722112-2016-00018, 3006722112-2015-00595.Apollo was unable to determine the root cause of the event, and therefore the specific device problem is unknown.However, apollo has tracked the complaints received for the event of "inflation".A total of (b)(4) complaints (including the one for which this letter is written) were received globally in the past 2 years for the event "inflation", through december 2015.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: balloon inflation is listed as a potential failure mode in the application and process failure mode and effects analyses (fmeas).The severity associated with balloon inflation and subsequent early device removal is listed as "serious injury" or 3 per our risk management sop.In each case, the frequency or mitigated occurrence is listed as "remote" or 2 per our risk management sop.Within the application fmea, the hazard or potential failure mode is "system becomes contaminated resulting in inadvertent balloon inflation" with a potential cause of "saline is not sterile".The controls in place to mitigate this hazard are user education, experience and training and the dfu states to fill the balloon with sterile saline.Within the process fmea, there were two hazards or potential failure modes listed.The first is "excessively coating the valve/deflation tool with sodium bicarbonate (sodium bicarbonate entering valve)." the second is "failing to firmly tap the valve to remove excess sodium bicarbonate (sodium bicarbonate entering valve)." for both of these hazards, the potential causes are "incomplete or missed steps/operations." the controls in place for both of the hazards are established by apollo within its sheath assembly manufacturing procedure - the validation of which is captured within the intragastric balloon process validation report- as well as the apollo quality system requirements for dhr review for a manufactured sheath assembly.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 27-jul-2017.Device evaluation summary: additional testing was performed on the device.Foreign matter was noted in the valve chamber.The slit valve was removed from the device using a razor blade for testing.Pressure testing of the slit valve was performed, the outside to inside pressure was noted to be 1.89 psi.The inside to outside pressure was noted to be 10 psi.The valve was cross-sectioned along the sealing mechanism, and examined microscopically with a magnification between 20x-60x.The surface of sealing mechanism showed typical axial lines parallel to the valve access due to the blade cutting direction during valve manufacturing.The inner edge of the cut appeared to be more defined than the opposite edge, a likely consequence of the valve slitting process.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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 leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5339054
• MDR Text Key: 34822874
• Report Number: 3006722112-2015-00595
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2017
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2017
• Device Model Number: N/A
• Device Catalogue Number: B-4800
• Device Lot Number: RWAP6396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided; 03/01/2017
• Supplement Dates FDA Received: 03/18/2016; 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR