MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 04/10/2012

Event Type  Death  

Event Description

Reported events of death, "abdominal haemorrhaging", "cardiac arrest", and "fatal heart attack" within one patient following gastric band surgery from media article "mum died after gastric band operation", hannah jennings-parry, solihull news, solihull_news@mm.Co.Uk, may 19, 2014.Although the manufacturer of the device is unknown, it is allergan's approach to compliance to resolve all doubt in favor of reporting.

Manufacturer Narrative

Taper unknown.The author of the article was asked to return the product for a device analysis as well as to indicate the product serial number, the date of the event, and the implant and explant dates.This information has not yet been received by allergan.The connector type cannot be identified nor an assumption be made as to the type of connector associated with this complaint because no serial number or implant date was given.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.Death, cardiopulmonary arrest, and hemorrhage are surgical and physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding the serial number and the implant date has been requested.Device labeling addresses the reported event of death as follows: "laparoscopic or laparotomic placement of the lap-band system is major surgery and death can occur." device labeling addresses the reported event of hemorrhage as follows: "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." allergan also states in the dfu for the product: "precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.".

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNKNOWN ALLERGAN; 71 south los carneros road; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3910057
• MDR Text Key: 16447481
• Report Number: 2024601-2014-00317
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/19/2014

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 ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/13/2014
• 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): Death
• Patient Age: 61 YR