MAUDE Adverse Event Report: ALLERGAN LAP-BAND ACCESS PORT KIT (UNK SIZE)

Catalog Number LAP-BAND ACCESS PORT KIT (UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Regurgitation (2259); Weight Changes (2607)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Health professional reported the port was explanted with conversion to the gastric sleeve due to patient complaining of unsatisfactory weight loss and "a very tight or narrow opening through the lap-band (sic) with dilation of the esophagus." patient "had series of fills and unfills and was not consistently able to lose weight after that time," first noticed when the patient "began to gradually gain back weight" and when "patient going through cycles of fills and unfills after first year." patient also had a history with "reflux" while the band was implanted.

Manufacturer Narrative

Taper ii.Allergan has received the product however the device has not been identified nor has the analysis been completed at this time.Based upon the implant date provided by the reporter the connector type is assumed to be a taper ii.Esophageal dilatation, reflux and unsatisfactory weight loss are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: LAP-BAND ACCESS PORT KIT (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNKNOWN ALLERGAN; 71 s. los carneros; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4172543
• MDR Text Key: 5160805
• Report Number: 2024601-2014-00562
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2014

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: Health Professional
• Device Catalogue Number: LAP-BAND ACCESS PORT KIT (UNK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Weight: 130