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

Catalog Number LAP-BAND AP ADJUSTABLE GASTRIC

Device Problem Device Slipped (1584)

Patient Problems Syncope (1610); Dyspnea (1816); Vomiting (2144); Dizziness (2194); Obstruction/Occlusion (2422)

Event Date 06/02/2015

Event Type  Injury  

Event Description

Patient reported "aspirating vomit" during use of cpap equipment, after implant with lap-band.Patient indicated that some incidents were so severe that they were unable to breathe for several seconds.The restriction of the band was lessened and then completely "deflated", however the patient's most recent incident caused them to "aspirate vomit" and was not able to breathe for several seconds.The patient became dizzy and almost lost consciousness.The patient was taken tot the emergency room.Additional findings" the lap-band was explanted.Additional findings: healthcare professional reported, "explanted due to high band position at ge junction and fibrous band obstruction".

Manufacturer Narrative

Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon implant date and explant date provided by the reporter the connector type is assumed to be a taper ii.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.Band slippage, obstruction, vomiting, syncope, dyspnea and dizziness are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the catalog number, serial number, the event date, patient data or further event details.Device labeling addresses the reported event of band slippage and obstruction as follows: "obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion, or patient non-compliance regarding choice and chewing of food." device labeling addresses the reported event of vomiting as follows: "nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended." device labeling addresses the potential of syncope, dyspnea and dizziness as follows: "it is important to discuss all possible complications and adverse events with your patient.Complication 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.".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78746 ; 8555513123
• MDR Report Key: 4911511
• MDR Text Key: 17218275
• Report Number: 3006722112-2015-00201
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

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: Health Professional
• Device Catalogue Number: LAP-BAND AP ADJUSTABLE GASTRIC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/10/2015
• 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
• Treatment: METFORMIN; LISINOPRIL-HCTZ
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR