MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Model Number C-20360

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2021

Event Type  malfunction  

Event Description

It was reported on 06-dec-2021 that a patient underwent a port revision on (b)(6) 2021.Per the report: "port wound re-opened to reveal sharp angulation of tubing and collar going into abdomen from the port.The entry site to abdomen from edge of port was far too short resulting in tubing angle of 180 degrees with tubing going back on itself into the abdomen, underneath the port.The protective collar had broken free and was some 5cm along the tubing inside the abdomen.Old port removed and new port attached after system flushed nsaline.Defect in fascia from removing old port repaired with onlay prolene mesh 3x3cm using prolene sutures, new access aps port attached to fresh area of fascia more medial to previous site so allowing flat lie of the rigid port collar before the soft part of the port tubing entered the abdomen on a gentle curve of less than 90 degrees." it was noted that on 21-jul-2018 the nurse apt notes stated: "very difficult port ? flipped cr accessed 1.5ml very yellow fluid aspirated.I was unable to instil any fluid.I accessed the port again easily - could withdrawn - but only bubbles as band aspirated but again could not re instil any fluid." the patient had an xray performed on (b)(6) 2018.Per the nurse apt notes, "it was not possible to either inflate or deflate the band via the port despite good positioning of the needle in the port.Port replacement surgery advised following patient meeting." the site confirmed, via email, that the implanting physician used sutures to attach the access port.

Manufacturer Narrative

The observed failure appears to be consistent with an overlarge down or lateral application of mechanical stress to the tube at or near the external collar of the port housing.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: michelle ravert ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 13063857
• MDR Text Key: 285434798
• Report Number: 3013508647-2021-00045
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Model Number: C-20360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: 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: 34 YR
• Patient Sex: Male
• Patient Weight: 116 KG