MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on: 09/15/2015.The reporter of the complaint was asked to return the product for analysis, as well as to indicate the product serial number.To date, apollo has not received the product or further information regarding serial number.Without serial number or device model, taper type cannot be determined.Visual examination may determine the connector type associated with this report.Labeling addresses the possibility of buckle disengagement as follows: warning: "failure to secure the band properly may result in its subsequent displacement and necessitate a second operation." caution: "failure to use an appropriate atraumatic instrument to lock the band may result in damage to the band or injury to surrounding tissues.".

Event Description

Reported as: shortly after placement of the lap-band system, the patient lost resistance.According to the physician, evidence showed the actual band was not closed.No diagnostic tests were noted in the chart.The lap-band system was explanted, and the physician noted a fracture in the buckling system with no other abnormalities in the area.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5078808
• MDR Text Key: 25855562
• Report Number: 3006722112-2015-00350
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 123