MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP LARGE WITH ACCESS PORT II; ADJUSTABLE GASTRIC BAND

Model Number B-2265

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Sepsis (2067)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii : the reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connecter type is assumed to be a taper ii.Further information has been requested of the initial reporter regarding further clarification on the reported event, the explanting physician, and relevant patient history.To date, no additional information has been received by apollo.Device labeling addresses possible outcomes of pain and sepsis as follows: warnings: 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.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.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.

Event Description

Reported as: a patient with the lap-band system was reported to have "had abdominal pain, presented to hospital and found to have free fluid and sepsis, band explanted.Patient presented to hospital and was taken to the operating room.Patient wants the band replaced.".

• Brand Name: LAP-BAND AP LARGE WITH ACCESS PORT II
• 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
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica, cs ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5555132
• MDR Text Key: 42091388
• Report Number: 3006722112-2016-00072
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020237
• UDI-Public: 10811955020237
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/14/2015
• Device Model Number: B-2265
• Device Catalogue Number: B-2265
• Device Lot Number: 2405457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• 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: 42 YR