MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number UNK LAP-BAND

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Not Applicable (3189)

Event Date 08/22/2015

Event Type  malfunction  

Manufacturer Narrative

Taper unknown.The reporter of the complaint was asked to return the product for analysis as well as to indicate the product serial number, date of event, implant date and explant date.The 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.Device labeling addresses the reported event of user error as follows: "surgeons planning laparoscopic placement must have extensive advanced laparoscopic experience, i.E., fundoplications as well as previous experience in treating obese patients, and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures.They should comply with the american society of metabolic and bariatric surgeons (asmbs) and the society of american gastrointestinal endoscopic surgeons (sages) joint ¿guidelines for surgical treatment of morbid obesity¿ and the sages ¿guidelines for framework for post-residency surgical education and training¿.Surgeon participation in a training program authorized by allergan or by an authorized allergan distributor is required prior to use of the lap-band¿ system.

Event Description

Healthcare professional reported "implanting surgeon has damaged the port and there is evidence that the surgeon tried to fix the damage." device has been explanted.

Manufacturer Narrative

Taper ii.Supplement #1 - device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connecter type as taper ii.Visual inspection was performed and noted two sutures tied around the port tubing, one of which appeared to have caused damage to the port tubing.One suture was observed to be attached to the port hole.An air leak test was performed on the port tubing and leakage was observed from the area tied with the suture.A fill test was performed on the port and no blockage or resistance to flow was noted.A microscopic analysis was performed and noted striations consistent with damage of a surgical tool on the port tubing near the sutures.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• 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: 5112056
• MDR Text Key: 27063000
• Report Number: 3006722112-2015-00374
• 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,health professional,o
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LAP-BAND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 28 YR