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

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Weight Changes (2607)

Event Date 04/24/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing, and as additional information becomes available, a supplemental report will be made.At this time, the reported issue will be tracked and trended.D6a: literature author stated the device was implanted in 2008, and explanted in 2019 but didn't specify the exact dates.

Event Description

Literature review performed: early operation for complications arising from bariatric surgical tourism.Jonathan andrew mckenzie, md, mba(1), peter drevets, md(1), aaron bolduc, md(1), jacob greenberg, md, edm(1) and lisa renee hilton, md(1).1.Department of surgery, medical college of georgia at augusta university, augusta, ga usa.The american surgeon 2022, vol.88(8) 1907-1908 doi: 10.1177/00031348221086798 first published online: 24apr2022.This article noted a 48-year old female patient who underwent lagb in tijuana, mexico, via a bariatric medical tourism in 2008.She had no follow up after surgery.Subsequently had a port infection approximately four years after implant, for which the port was removed, but the band was left in place.Suffered with chronic abdominal pain for many years before the retained band was recognized.During band removal (in 2019), it was discovered that she had complete band erosion.After removal, her symptoms resolved.This case demonstrates the issues with bariatric medical tourism.Specifically, because of the lack of appropriate follow up.Follow up and monitoring after surgery is important for preventing bariatric surgery complications and assisting with adequate weight loss.The other aspect of the case is the importance to recognize bariatric surgery complications.Port infection should warrant an investigation for potential intra-abdominal sources.Band erosion is uncommon but known complication of lagb and requires band removal.This report is for the reported event of the explant of the lagb.A second report for the port removal in ~2012 is issued under mfr report number: 3013508647-2023-00281.

• 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: jazmin quiroz ; 1001 calle amanener; san clemente, CA 92673 ; 8779377374
• MDR Report Key: 16919745
• MDR Text Key: 315100211
• Report Number: 3013508647-2023-00284
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female