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)

Patient Problems Abscess (1690); Anemia (1706); Erosion (1750); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) date of event: captured as date of citation.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: eroded gastric band: where to next? an analysis of the largest contemporary series.Author: savio g.Barreto & jacob chisholm & anne-sophie mehdorn & jane collins & ann schloithe & lilian kow.Citation: obesity surgery (2020) 30:2469¿2474.Doi: https://doi.Org/10.1007/s11695-020-04610-4.The purpose of this retrospective study is to analyse the largest series of erosions following laparoscopic adjustable gastric band (lagb) published to-date with an aim to share our experience with this rare complication and how we managed this cohort of patients following explantation of their lagb.From january 1996 to january 2019, 2158 consecutive patients underwent primary labg.The ¿goldfinger¿ reticulating device (ethicon) was used to facilitate passage of the band through the tunnel that lies above the apex of the lesser sac and provides effective posterior fixation for the band.Anterior fixation was undertaken with 3 to 4 tunnelating sutures using 2/0 ethibond (ethicon) between the small proximal pouch and the stomach distal to the band.Lagb erosions was reported in 102 patients (female n=96, male n=6, median of 43 years with range of 18-62 and median preoperative bmi of 43 kg/m2 with range of 25-68kg/m2).Clinical presentation of band erosion included loss of restriction (n=43), epigastric pain (n=29), recurrent port infections (n=8), weight regain (n=5), regurgitation/reflux (n=5), fever (n=4), nausea/vomiting (n=3), general unwellness (n=3), anaemia (n=2), back pain (n=2) and splenic abscess (n=2) in which a single patient may have more than 1 symptom.Endoscopic, laparoscopic approach, and conversion to open procedure were the method of removal of the eroded bands.The risk of re-erosion is increased in patients who undergo repeat agb following a previous episode of erosion.Repeat lagb should not be offered after a previous erosion.Lsg, rygb and oagb-mgb should be considered as appropriate revisional procedures in patients who experience weight regain following explantation of an eroded lagb.

• 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: 11223926
• MDR Text Key: 228619821
• Report Number: 3005075853-2021-00445
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention