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

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 05/13/2013

Event Type  Injury  

Event Description

Some years after laparoscopic placement of a lapband device to treat obesity, developed left sided pain.Imaging showed that the band between the port and lapband had fractured.The device was laparoscopically removed.In going through hospital line records i came across the gross pathology report.Lap gastric band and port: gross examination performed.Clinical: prolapsed band.Gross: the specimen is received fresh in a container labeled with the patient¿s name, ¿(b)(6)¿, the medical record number, and ¿lap gastric band and port¿.It consists of two pieces of white plastic and metal.One portion measures 18 cm in length x up to 1.5 cm in diameter.The other portion measures 40 cm in length and consists of plastic tubing with a diameter of 0.4 cm and a metal and plastic port measuring 3 x 3 x 1.5 cm.Inscribed on the metal part of the port is: ¿port-a-cath m52996¿.The specimen is received for gross examination and was reviewed by dr.(b)(6).Gross pathology specimen in two pieces - the lapband and the port.Note that the reporting physician is the patient.Diagnosis or reason for use: obesity.Is the product compounded? no.

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.
• MDR Report Key: 8206273
• MDR Text Key: 131939545
• Report Number: MW5082680
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 78