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

Catalog Number	C-2365
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Heartburn/Indigestion (1883); Unspecified Infection (1930); Pain (1994)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Report, (mw5159479) was received through fda's medwatch program.The patient presented with mild epigastric pain and reflux and upper endoscopy was performed, which revealed eroded lap-band and lap band removal was recommended.Lap band was found penetrating in the cardia on the greater curve side.No inflammation was really noted.The surgeon cut the lap band into pieces to remove and one was left behind, which they had to go back to retrieve.
Additional Manufacturer Narrative
The reported device was not available for physical evaluation.The investigation involved communication via email with the reporter to clarify the description of the event, and the analysis of relevant information provided in view of supporting the identification of possible causes for the adverse event.The investigation involved the analysys of the lot history records of the lap-band device involved.Lot history record was reviewed, and no discrepancies or non-conformance's were recorded.The product was manufactured according to specifications.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.Limited investigation does not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
Report # mw5162807 was received through fda's medwatch program.The report received is a duplicate of report # mw5159479.The patient presented with mild epigastric pain and reflux and upper endoscopy was performed, which revealed eroded lap-band and lap band removal was recommended.Lap band was found penetrating in the cardia on the greater curve side.No inflammation was really noted.The surgeon cut the lap band into pieces to remove and one was left behind, which they had to go back to retrieve.
Additional Manufacturer Narrative
A letter was received from fda medwatch program with report # mw5162807; the report was reviewed it and was discovered that this report is the same as the mw515979 report sent to apollo endosurgery, inc.On (b)(6) 2024.We consider this a duplicate report and will not document it as a new complaint.Consequently, a new mdr will not be submitted.A response was sent to fda with the explanation in (b)(6), 2024.

• Brand Name: LAP-BAND SYSTEM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 7625 golden triangle drive; suite g; eden prairie MN 55344
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 7625 golden triangle drive; suite g; eden prairie MN 55344
• Manufacturer Contact: maria quiroz ; 7625 golden triangle drive; suite g; eden prairie, MN 55344 ; 8449377374
• MDR Report Key: 20729653
• Report Number: 3013508647-2024-00069
• Device Sequence Number: 21070171
• Product Code: LTI
• UDI-Device Identifier: 00850007764654
• UDI-Public: 00850007764654
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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?: No
• Device Expiration Date: 06/11/2023
• Device Catalogue Number: C-2365
• Device Lot Number: 75EA2685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown