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| Model Number 7000 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Abdominal Pain (1685)
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Event Type
Injury
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Manufacturer Narrative
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Obalon does not believe that there is sufficient information to reasonably suggest that the 3-month obalon balloons caused or contributed to the onset of pancreatitis.For example, when questioned, neither the treating physician nor the author of the cited literature were able to provide documentation or other information which supports the characterization of the event as published.In general, it is expected that an author of a published medical article would maintain records or other supporting documentation regarding their work.It is unclear why the author did not have copies of medical records nor recollection of the facts to support this event, particularly considering the recent publication date of his article.In this case, both the primary physician and obalon's medical reviewer have evaluated the underlying facts and determined that, in their medical judgment, in addition to the lack of documentation and inconsistent characterizations of the subject event, it is unlikely that the obalon balloons caused or contributed to the event from a medical perspective.Since the two implanted balloons were not deflated or removed from the patient at the time of the reported event.If the balloons were the cause of the pancreatitis, either the pancreatitis would not have resolved, or it most likely would have returned during the course of the balloon therapy.To the contrary, per the publication the pancreatitis resolved, and the balloons remained implanted for the full duration of treatment (90 days) without reoccurrence and no defect/malfunction of the balloons was identified at removal.It should also be noted that the 3-month obalon balloon system that was the device utilized in the patient to this investigation is with respect to the 3-month obalon balloon system and does not involve a us marketed product.Specifically, the 3-month balloon is not approved for use in the us.Even though the 3-month balloon is similar to the commercialized 6-month balloon the 3-month balloons were inflated with a different inflation gas and pressure profile in addition to other design variations of the balloon and the accessories.Per the mdr regulation, events that occur outside of the us and that involve devices that are not commercialized domestically are only reportable in the event that the devices malfunction and are similar to the us marketed version.In this case, there is no information which reasonably suggests that the balloons related to this event failed to meet their specifications or otherwise perform as intended.Rather, as noted above, the balloons remained implanted for the full duration of treatment and was based on anecdotal evidence.The following warnings currently included in the ifu include symptoms of an onset of pancreatitis: each patient should be monitored closely during the entire device therapy period in order to detect the development of possible complications.Patients should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, esophageal injury or perforation, gastric perforation, and other possible complications that could occur, and should be advised to contact their physician if these symptoms worsen over time or persist for more than 24 hours.An earlier than expected endoscopic removal may be required if there is a new onset of symptoms or ongoing gastrointestinal symptoms where an x-ray has ruled out balloon deflation or obstruction, but the patient's symptoms remain unresponsive to other medical management methods.In summary, there is no information to reasonably suggest that the balloons caused or contributed to the reported case of pancreatitis and there were no reported device malfunctions.
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Event Description
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This report is not an admission that the device caused or contributed to the event.The literature was anecdotal and could not be corroborated by evidence since no medical records could be provided.The device was not returned for analysis however obalon performed an investigation and found no evidence that reasonably suggests that the device may have caused or contributed to the event.Obalon is submitting a report since this article was published in literature.The following literature article was published online march 2, 2019 "acute pancreatitis as a complication of intragastric balloons: a case series".A patient in (b)(6) with two 3-month obalon balloons implanted was reported in the article to have developed acute pancreatitis with a serum lipase level of 808 iu/l.The 3 month balloon system was never commercially available in the united states and is different from the 6-month balloon system approved in the united states.The patient was reported to have been managed conservatively with intravenous fluids and analgesics for a few days and discharged home without removing the balloons.The authors hypothesize that the cause of pancreatitis associated with intragastric balloon placement are potentially two-fold: due to the mass effect from the balloon on the pancreas or due to dislodgment of the catheter to the second part of the duodenum.It remains unclear how the mass of the obalon balloon can be considered meaningful since each balloon is 3 grams or approximately the weight of a penny.The second potential cause is not valid since the catheter is removed at administration.On (b)(6) 2019, a teleconference was held with the prescribing physician of the patient described in the publication as developing pancreatitis while obalon balloons were implanted.The medical evaluation and treatment described below from the teleconference were per the physician's recollection.The reported pancreatitis event occurred approximately 2 years ago and involved a patient implanted with the 3-month obalon balloon system outside of the united states.The patient began complaining of abdominal pain after the second balloon was placed.The prescribing physician was unsure of the timing but stated that the onset of pancreatitis was within a month from the second balloon placement.The patient went to the emergency department at another hospital in (b)(6) (not where the obalon balloons were administered) and lab tests and an abdominal x-ray were performed.It is the prescribing physician's understanding that only the lipase may have been abnormal at a reported level of approximately 800.They said that no ct scans or ultrasounds were performed to rule out the prevalence of gallstones.In addition, neither a diabetes history or assessment of undiagnosed type 2 diabetes were performed.The patient's pain was treated with an analgesic and the patient was sent home that day without being admitted for hospitalization which is contradictory to the article description which stated patients were discharged after a few days.The pancreatitis resolved and the two balloons remained implanted for the full duration of treatment (90 days).The prescribing physician was asked for a copy of the patient's medical records and they stated they did not have them, did not have access to them, and that they are not available for request as the patient was treated at a hospital at which they did not have access records.They also stated that they were not involved in the treatment of the pancreatitis, but this was their recollection of the events based upon discussions with the emergency department.They also stated that based on his understanding of the facts and medical knowledge as a general surgeon, they were not convinced that the balloons caused or contributed to the pancreatitis and other contributing factors were not ruled out.The primary author of the publication responded to an email request for the patient's medical records to substantiate the claims made in the manuscript regarding the diagnoses and conclusions and any additional information regarding the subject event.They stated that they did not have access to the patient's medical records and suggested we reach out the obalon treating physician which had already occurred.Based on information obtained through interviews, the following statements in the literature publication were identified as contradictory to the information being provided: all patients had normal liver enzymes and bilirubin levels and ultrasound examination was performed on all of them and none had any gallstones or biliary dilation upon presentation.Per information provided by the prescribing physician, there was no evidence that the patient had gallstones, however he stated they were not ruled out.Other patients were managed conservatively with intravenous fluids and analgesia for few days and discharged home.Also, per information provided by the prescribing physician, the patient was not hospitalized, and the author of the publication could not provide medical records nor confirm the accuracy of either of these statements as they applied to the subject patient/event.Additionally an article discrepancy was identified in table 1 "duration of igb" where it is unclear if it is the implant duration or when the onset of symptoms occurred.An example is for case # 3 where the duration is 1 day with conservative management but the obalon case is identified as a duration of 90 days.Based on information provided by the prescribing physician, it was confirmed that the obalon balloons were removed at 90 days and that the onset was approximately within 1 month from when the 2nd balloon was placed.In addition to the correspondence with the treating physician and manuscript author, obalon also consulted with its own medical expert.Obalon's medical reviewer stated that it is not reasonably expected that if the onset of pancreatitis was related to the balloons that it would independently resolve or not return if the balloons remained implanted.
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Search Alerts/Recalls
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