MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Date 09/15/2013

Event Type  Injury  

Manufacturer Narrative

Information from original submission: unknown taper the device has not been returned to apollo.Without the device or device serial number, the taper type is unknown.If returned, visual examination may determine the connector type associated with the event.This event was captured in a literature article published in january 2016.Further information has been requested with one of the authors to obtain additional information such as implant date, explant date, physician, patient information, and device information.To date, apollo has not been able to obtain further information.Device labeling addresses the event as follows: 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.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.Nausea and vomiting may also be symptoms of stoma obstruction or a band/stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.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.Other adverse events considered related to the lap-band® system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.Other events reported to occur in only one patient per event included; abdominal discomfort, alopecia, anemia, arthralgia, decrease blood folate, flatulence, gastrointestinal motility disorder, bronchitis, chills, implant site infection, implant site irritation, implant site hemorrhage, night sweats, hypotrichosis, headache, nail infection, pyrexia, skin irritation, esophageal obstruction,esophageal spasm, postoperative infection, urinary tract infection, muscle spasms, depression, back pain, and hypertension 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.

Event Description

Reported event from journal article titled: "gastric lap-band infection due to mycobacterium abscessus presenting as new-onset ascites in a cirrhotic patient", infectious diseases volume 48.Reported events of 2 weeks progressive abdominal distention, nausea, fever, chills, and new-onset ascites.Diagnosed infection which was subsequently identified as m abscessus.Six weeks after the first ascitic fluid culture turned positive the patient was taken to the operating room for debridement of the involved area and removal of the lap-band.During the operation, gross purulence was noted around the subcutaneous access port, with pus tracking toward the lap-band along the connection tube.At this time, the patient started to bleed profusely from periumbilical varices, which led to haemodynamic instability.The access port was removed quickly, connection tubing was cut (which receded into the abdominal cavity) and the operation was terminated.The patient was transferred immediately to the intensive care unit, where she received multiple units of blood and fresh frozen plasma, resulting in haemodynamic stabilisation.Intra-operative cultures from a sample of the purulence around the lap-band grew m abscessus.The patient was referred to our hepatobiliary surgeon to determine whether the infected lap-band and the remaining portion of the connection tubing could be removed safely, because the multidrug- resistant m abscessus infection, with its limited antimicrobial options, could not be eradicated without complete lap-band removal.The patient returned to the operating room 3 weeks after the original surgery; lap-band and tubing were completely removed without incident.The lap-band was grossly infected.Post-operatively, the patient resumed intravenous antibiotic therapy with imipenem and tigecycline.The lap-band culture also grew candida albicans and candida krusei from intra-operative cultures and the patient received a short duration of caspofungin.The patient completed a 3-month course of imipenem and tigecycline following lap-band removal.Ascites and abdominal pain completely resolved.The patient was subsequently evaluated in the course of routine follow-up and there was no evidence of recurrent ascites or active infection.

Manufacturer Narrative

Unknown taper.

Manufacturer Narrative

This supplement #1 - medwatch was originally sent to the fda on (b)(6) 2017.A notification was received from the fda on (b)(6) 2020 requesting a re-submission of this report, as the supplment #1 report was not available in their database.Resubmission of this supplement #1 - medwatch was sent to the fda on (b)(6) 2020.Information from original submission on (b)(6) 2017: unknown taper supplement #1 - medwatch sent to the fda on (b)(6) 2017.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 6311271
• MDR Text Key: 148065330
• Report Number: 3006722112-2016-00225
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 141