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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Dysphagia/ Odynophagia (1815); Eructate (1839); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Vomiting (2144); Hernia (2240); Regurgitation (2259); Injury (2348); Blood Loss (2597)
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| Event Date 06/04/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Taper unknown.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connecter type associated with this event.Review of the device labeling notes the following: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Patients must be carefully counseled on the need for proper dietary habits.They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection.If necessary to avoid any nutritional deficiencies, the physician may choose to prescribe appropriate dietary supplements.The appropriate physical monitoring and dietary counseling should take place regularly.Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution.The use of such medications may be associated with an increased risk of erosion.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the us adult study, 42% of the patients undergoing revision surgery were reported to have adhesions involving the stomach.Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.There is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Reoperation to remove the device is required.Re-operation for band erosions may result in a gastrectomy of the affected area.Eroded bands have been removed gastroscopically in a very few cases.Consultation with other experienced lapband® system surgeons is strongly advised in these cases.Infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated.Warnings: patients should be advised that the lap-band ap® system is a long-term implant.Explant and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.Patients must be carefully counseled on the need to report all vomiting, abdominal pain or other gastrointestinal or nutritional issues as these symptoms may indicate a condition not related to the lap-band® system.
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Event Description
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Reported event from journal article titled: "stent-induced compression necrosis for the endoscopic removal of a partially eroded lap-band" summary of events; lap-band patient presented with dysphagia to solid foods, nausea, and non-biliary, non-bloody vomiting after warm meals.These complaints commenced after a surgical procedure 6 weeks earlier, in which two enterocutaneous fistula complexes, related to mesh infection, were removed.Patient had an extensive surgical history, including open placement of a lap-band 9 years earlier and numerous subsequent cicatricial hernia corrections.Lap-band was empty and in situ.Endoscopy revealed/showed a 60° lap-band erosion towards the gastric lumen, with the lap-band tubing partially connected to the lap-band.A hybrid procedure for lap-band removal was undesirable due to the presence of multiple extensive abdominal adhesions relating to a previous surgery.Considering patient's dysphagia complaints, the most appropriate treatment option seemed stent placement to accelerate lap-band erosion via compression necrosis for subsequent endoscopic removal.A stent was placed in the cardia, through the lap-band, under fluoroscopic visualization.One week post endoscopy, patient reported that eating solid foods was going reasonably well.Four weeks after stent placement, a follow-up endoscopy revealed a correctly positioned stent in the distal oesophagus.The stent was removed with a gripping forceps.In the stomach, a 160° eroded lap-band was found.Still, removal of the lap-band with a grasping forceps was impossible therefore another stent was placed.Three weeks after the procedure, the patient expressed a desire for early stent removal due to complaints of tender feeling in the chest, ructus, and dysphagia probably related to an overly proximally (oesophageal) positioned stent.Patient was advised to tolerate these complaints for the upcoming 5 weeks, since the stent had previously remained in situ for four weeks with insufficient result.Two months after the placement of the second stent, endoscopy revealed a fully eroded lap-band free in the gastric lumen.Inspection in retroversion showed obvious fistula openings, but sight was limited due to food retention.Some mucosal damage and bleeding were seen in the distal oesophagus, but check-up after removal showed no more lacerations.The lap-band and the stent were removed using an endoscopic loop.Directly after the transoral removal of the lap-band, the patient reported tender throat and difficulty swallowing liquids and solids, which both resolved after one day.Six months after the final endoscopic intervention, patient reported complete relief of the symptoms of dysphagia for which patient was admitted earlier.Per the author, the pre-existent erosion may be associated with the formation of a strong fibrous migration-retarding capsule surrounding the lap-band, especially considering the extensive abdominal fibrous inflammation due to patient's surgical history.
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Event Description
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Additional information per follow up: the patient's port was removed approximately two years prior to lap-band removal due to "port infection" and computed tomography (ct) scan confirmed "abdominal wall abscess".
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Manufacturer Narrative
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Supplement #1: medwatch sent to fda on 10/08/2018.
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Search Alerts/Recalls
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