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

Model Number C-20306

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2021

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2021 that patient underwent explant surgery on (b)(6) 2021 to have a port removed.The patient was initially implanted with the device on (b)(6) 2016.Per the complaint description: "no signs of infection.Mobile port in subcutaneous tissues.Mesh attached but adherent to fat which was equally mobile.Port detached and removed.".Per the nurses notes from (b)(6) 2021, "nurse unable to access port to do aspiration due to patient struggling.Patient previously has had issues with port access, patient referred to patient meeting where port surgery was advised." x-ray the port was discovered to be detached via x-ray findings.Per the site, the port appeared side on initially.As the health care professional went to cannulate the port, it appeared to turn and looked en face.The needle touched the centre of the port but the health care professional was unable to cannulate it, as there seemed to be a hard end point raising the concern for a flipped port.The health care professional advised surgical review and revision of the port.During the revision surgery, the patient had the port removed and a new port was implanting during the procedure.It was noted by the site that, during the initial implant procedure on (b)(6) 2016, the access port was implanted using sutures.

Manufacturer Narrative

The investigation was unable to determine the cause for the port to become mobile in subcutaneous tissue.The port needles were not used and the port was fixated using sutures.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente 92673
• Manufacturer Contact: michelle ravert ; 1001 calle amanecer; san clemente 92673 ; 8449377374
• MDR Report Key: 13064382
• MDR Text Key: 285609033
• Report Number: 3013508647-2021-00046
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C-20306
• Device Lot Number: 20812873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 85 KG