MAUDE Adverse Event Report: ALLERGAN AP STANDARD RAPID-PORT EZ

Catalog Number B-2360

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

Patient Problems Vomiting (2144); Weight Changes (2607)

Event Date 05/13/2013

Event Type  Injury  

Event Description

Company representative reported a lap-band system which the pt "had for many years and didn't lose weight." the lap-band system was explanted and not replaced.Follow-up info: healthcare professional reported, "pt had intermittent problems with vomiting, missing fluid one time.Pt unhappy with weight loss, requested and approved for conversion to sleeve.".

Manufacturer Narrative

Rapidport ez strain relief.Medwatch sent to fda on: (b)(4) 2014.The access port connector associated with this report has not been returned and was discarded after surgery by the reporter.Based upon the catalog number, serial number and implant date provided by the reporter the connector type is assumed to be a rapidport ez strain relief.Vomiting and weight fluctuation are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event of vomiting as follows: "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, or re-operation to reposition or remove the device may be required." device labeling addresses the possible outcome of inadequate weight loss as follows: "caution: insufficient weight loss may be a symptom of inadequate restriction (band to loose), pouch or esophageal enlargement, and may be accompanied by other symptoms, such as heartburn, regurgitation or vomiting.If this is the case, inflation of the band would not be appropriate.".

• Brand Name: AP STANDARD RAPID-PORT EZ
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zone franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 s. los carneros rd.; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3611954
• MDR Text Key: 4093452
• Report Number: 2024601-2014-00054
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

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 Expiration Date: 08/12/2013
• Device Catalogue Number: B-2360
• Device Lot Number: 2158473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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): Other
• Patient Age: 30 YR