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

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Pain (1994); Perforation (2001); Weight Changes (2607); Gastrointestinal Regurgitation (4477)

Event Date 12/17/2018

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.During the study period, 211 patients underwent lagb removal (87.7% female).Most bands were inserted out of the province where the explant care was provided.Reasons for band removal included dysphagia, band slip and weight recidivism.Fifty-nine patients (28%) underwent revision surgery at a mean of 12.8 ± 9.3 (range 0-55) months after lagb removal.Mean age was 47 ± 9.7 (range 26-63) years, and mean pre-lagb weight was 131.0 ± 30.0 kg.Following lagb, the mean weight decreased to 120.5 ± 26.4 kg, but most regained weight after removal to a mean prerevision weight of 125.1 ± 27.0 kg.The lowest mean weight was achieved 12 months after revision surgery (98.7 ± 30.2 kg).The mean percent total weight loss was not significantly different after revision laparoscopic roux-eny gastric bypass compared with revision laparoscopic sleeve gastrectomy (22.8 ± 9.6% v.17.5 ± 6.5%, p = 0.179).The overall revision surgery 30-day complication rate was 18.6% and increased to 23.7% long-term.No deaths occurred.D6b: study examined outcomes for bands explanted between january 2008 and december 2016, but didn't identify exact dates for the explanted devices.H6: medical device problem code: literature states "port problems" as a reason for device explant.Using insufficient information code until more information becomes available.

Event Description

Literature review performed: the fate of laparoscopic adjustable gastric band removal.Vanessa falk, md(1), caroline sheppard, phd(2), aliyah kanji, md(1)(2), daniel birch, md(1)(2), shazeer karmali, md, mph(1) (2), christopher de gara, mb, ms(1)(2).1 - division of general surgery, university of alberta, edmonton, alta.2 - the centre for advancement of minimally invasive surgery, royal alexandra hospital, edmonton, alta.Canandian journal of surgery, vol.62, no.5, october 2019.This published article describes a single-center retrospective review of patients who underwent lagb explants between january 2008 and december 2016.A subset of patients who underwent revision surgery was then analyzed for patient demographics, weight, body mass index and postoperative complications.During the study period, 211 patients underwent lagb removal (87.7% female).Most bands were inserted out of province.Reasons for band removal included dysphagia, band slip and weight recidivism.Accepted for publication: 17dec2018.

• 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: 16993482
• MDR Text Key: 315853739
• Report Number: 3013508647-2023-00371
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 04/25/2023
• 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): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 125 KG