MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ALLERGAN LAP-BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problems Adhesion(s) (1695); Vascular Dissection (3160)

Event Date 09/12/2017

Event Type  malfunction  

Event Description

Patient had adjustable gastric band placed approx.Nine years ago.She has had several adjustments done with the latest approx.One year ago.No dysphagia or gerd.Had history of unfill due to ugi showing slip last year with improvement noted.However, there has been difficulty in accessing the port (catheter kink vs.Band leak).Options discussed band removal or band revision.Procedure done five months ago: laparoscopic revision (removal and replacement) of adjustable gastric band, relocation of port, heller myotomy, excision of cicatrix, takedown of fundoplication, lysis of adhesions.Pre-op diagnosis: gastric band malfunction, obesity class i, bmi 30-34.9.Post-op diagnosis: same as above, gastric band slippage.Findings: lap-band port was dissected from the subcutaneous pocket and excised out thro this incision.The catheter was fractured 2 inches from the port and completely disconnected.The lap-band was seen to have slipped and was moderate in size.There was a moderate-sized hernia sac which was excised.

• Brand Name: ALLERGAN LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s capital of tx hwy bldg 1, ste 300; austin TX 78746
• MDR Report Key: 7776703
• MDR Text Key: 116897336
• Report Number: 7776703
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 83