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

Device Problem Unintended Movement (3026)

Patient Problems Anemia (1706); Erosion (1750); Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Gastrointestinal Regurgitation (4477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing, and as additional information becomes available including whether or not the devices identified in the published article were lap-band, a supplemental report will be made.At this time, the reported issue will be tracked and trended.A2 age: mean age at removal was 57 years (range, 35-67).D6b: literature author stated the devices were explanted between 2009 and 2019 but didn't specify the exact dates.Erosion group characteristics in the erosion group (n 5 22), 16 (73%) were female.The american society of anesthesiologists class was 2 (range 2-3).Thirteen patients (59%) had obstructive sleep apnea, 11 (50%) had hypertension, 9 (41%) had hyperlipidemia, 7 (32%) had diabetes, and 10 (45%) had gastroesophageal reflux disease.Mean time from placement to removal was 7.2 years (range, 2-12).Mean body mass index at removal was 40 (range, 27.5-58.7).Mean age at removal was 57 years (range, 35-67).Seven patients (32%) underwent laparoscopic removal of the lagb and 14 (64%) underwent endoscopic removal.One patient (4%) underwent combined laparoscopic and endoscopic approach.Presentation and diagnosis of erosion patients who had an eroded lagb presented with a variety of symptoms, including abdominal pain (59%), anemia (9%), dysphagia (36%), gastrointestinal bleeding (9%), port infection (14%), nausea (23%), reflux (18%), and weight regain (27%).One patient was asymptomatic.Workup for diagnosis of band erosion was performed using a variety of modalities.Six patients were diagnosed by computed tomography scan, 3 patients were diagnosed by upper gastrointestinal radiography, and 10 patients were found to have erosion with upper endoscopy.The remaining 3 patients were found to have erosion at the time of surgery and not identified preoperatively.

Event Description

Literature review performed: endoscopic removal of eroded laparoscopic adjustable gastric bands: a preferred approach.Todd j.Robinson, d.O.(a), celine soriano, m.D.(a), michael larsen, m.D.(b), mohan k.Mallipeddi, m.D.(a), jeffrey a.Hunter, m.D.(a), lily chang, m.D(a).A.Department of general, thoracic, and vascular surgery, virginia mason medical center, seattle, washington.B.Department of gastroenterology, virginia mason medical center, seattle, washington.Surgery for obesity and related diseases 16 (2020) 1030-1034.This published article described a single-center, retrospective review of a prospectively maintained database to identify patients who underwent lagb removal from 2009 to 2019.The subset of patients with band erosion were identified for the study.The patient characteristics, presenting symptoms, diagnostic modalities and method of band extraction were analyzed.A total of 132 patients underwent lagb removal during the study period, among whom 22 (16.7%) patients were diagnosed with erosion.Seven (32%) patients underwent laparoscopic removal, 14 (64%) patients underwent endoscopic removal, and 1 patient (4%) underwent combined laparoscopic and endoscopic approach.These latter patients had variable amounts of erosion and buckle visibility, but all underwent endoscopic retrieval.

• 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: 16919739
• MDR Text Key: 315854071
• Report Number: 3013508647-2023-00338
• 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: 57 YR
• Patient Sex: Female