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

Device Problem Device Slipped (1584)

Patient Problems Adhesion(s) (1695); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Renal Failure (2041); Vomiting (2144); Hernia (2240); Peritonitis (2252)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked if the product was available for analysis and to provide device information.To date, apollo has not been able to confirm device information from the reporter and the device manufacturer is unknown.Further information has been requested of the reporter regarding: implant date, explant date, date of occurrence, and additional patient information.To date, no additional information has been received by apollo.A review of the device labeling notes the following: precautions: it is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Do not push the tip of any instrument against the stomach wall or use excessive electrocautery.Stomach perforation or damage may result in peritonitis and death.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.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.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.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

Literature review performed: "laparoscopic management of gastric perforation secondary to mesenteroaxial volvulus in a patient with laparoscopic adjustable gastric banding." paya-liorente c, et al.Asian j endosc surg.2018 mar 7.Case presentation: patient "was admitted to the emergency department with a 2-week history of alimentary vomiting, which was occurring with increasing frequency." the patient "had undergone laparoscopic adjustable gastric banding 6 years earlier." an initial examination revealed epigastric pain.Laboratory findings showed acute renal failure and an abdominal ct scan showed band slippage, leading to the formation of mesenteroaxial gastric volvulus and ischemia on the gastric wall."emergent diagnostic laparoscopy was performed, and severe peritonitis and gastric necrosis caused by volvulation was found." it was observed that there was a herniation of the greater curvature through the band and subsequent volvulus."the rotation's axis had firm adhesion between the banding's pseudocapsule and the gastrohepatic ligament." "after band removal, a fundal perforation was noted." fourteen months later the patient remained asymptomatic.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 7953929
• MDR Text Key: 123362691
• Report Number: 3006722112-2018-00258
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR