MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number AP STANDARD

Device Problem Device Slipped (1584)

Patient Problems Dehydration (1807); Obstruction/Occlusion (2422); Weight Changes (2607)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The product associated with this complaint will not be returned.Further information regarding implant date and device serial number has been requested of the implanting physician.To date, no additional information has been received by apollo.Without serial, catalog, or model number, the taper type associated with this event cannot be determined.Device labeling addresses the possible outcome of band slip as follows: warning: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Adverse events: band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.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.Caution: patients should be advised that the lapband® 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 as: the patient arrived at the er very malnourished, thin, and dehydrated.Patient had a gastric prolapse and gastric obstruction.Patient had the entire lap-band system explanted.

Manufacturer Narrative

Rapidport ez strain relief.Supplement # 1 - medwatch sent to fda on: 11/02/2015.Based on the serial number provided, it is assumed this device's access port configuration is a rapidport ez strain relief.

• Brand Name: LAP-BAND AP STANDARD WITH RAPIDPORT EZ
• Type of Device: ADJUSTABLE GASTRIC BAND
• 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5105306
• MDR Text Key: 26801824
• Report Number: 3006722112-2015-00389
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/28/2013
• Device Model Number: AP STANDARD
• Device Catalogue Number: B-2360
• Device Lot Number: 2153326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2011
• 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: 28 YR