MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Erosion (1750)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: exact date unknown, captured as citation date.Batch # unk.(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: swedish adjustable gastric band by videolaparoscopy: 5 and 10 years follow up author: omelanczuk p.Citation: surgery for obesity and related diseases.2019 oct; conference: the 36th asmbs.Annual meeting.United states.15 (10 supplement): s250-s251.Doi: not reported.This retrospective study aims to show the results of five and ten years follow up in patients with morbid obesity surgically treated by video laparoscopy placing a swedish adjustable gastric band.A total of 80 patients (mean age of 40, sex ratio if 83% female, 17% male and mean preoperative bmi 47.13 kg/m2).A swedish adjustable gastric band (ethicon) was placed by video laparoscopy.Acute complication including laceration of the liver (n=unknown) and port infection(n=unknown) were reported.Late complications were erosion (n=0.9%) and slippeage (n=1.3%).Forty had a conversion to rygb (n=28) and sleeve gastrectomy (n=4).The surgical treatment of obesity by placing and adjustable gastric band, results at 10 years are not good in terms of weight loss, complications, and the need of conversion to another bariatric procedure.All patients need a well as a strict follow-up in order to get good results.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 11167469
• MDR Text Key: 227001578
• Report Number: 3005075853-2021-00265
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention