MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.No specific patient information regarding this general event has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: surgery for obesity and related diseases.2016; 12: 849 855 (b)(4).

Event Description

It was reported in journal article title: management of gastric fold herniation after laparoscopic adjustable gastric banded plication: a single-center experience authors: po-chih chang, m.D.; anshuman dev, m.D.; abhishek katakwar, m.D.; ming-che hsin, m.D.; chi-ming tai, m.D.; chih-kun huang, m.D.Citation: surgery for obesity and related diseases.2016; 12: 849 855 this retrospective study reported on complications of laparoscopic adjustable gastric banded plication (lagbp) and discuss the clinical features and diagnostic and therapeutic strategies in such situations, with emphasis on gastric fold herniation (gfh).A total of 223 patients (74 men and 149 women; age range: 18 to 60 years old) who underwent lagbp for morbid obesity between august 2009 and december 2014 were included and analyzed in this study.For the first 70 patients during the surgical procedure included placement of an adjustable gastric band using the standard pars flaccida technique, then dissection of the greater omentum from antrum (3 cm from pylorus) to angle of his, calibration with a fr 38 orogastric tube, 2-layer plication (from angle of his to antrum) with first layer by interrupted ethibond 2-0 excel sutures and second layer by continuous ethibond 2-0 excel sutures, extension of the silicon tube of the adjustable gastric band through the umbilicus, and placement of the access port in the subcutaneous space.In (b)(6) 2012, the authors modified the surgical techniques and switched from a ¿banding-first¿ method to a ¿plication-first¿ technique to facilitate complete fundus plication for the subsequent 153 patients.Secondly, the authors replaced the second layer plication from ethibond 2-o excel to continuous prolene 2-0 sutures to tighten the outer layer of greater curvature plication.Reported complications included trocar site hernia (n-1); band leak (n-1); and gastric stenosis (n-1) which required re-admission;.It was concluded that the lagbp is a well-tolerated, non-resectional bariatric procedure with acceptable results.A high index of clinical suspicion followed by radiological investigations with early surgical intervention is the key to successful treatment of gfhs.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7611252
• MDR Text Key: 111438945
• Report Number: 2210968-2018-73532
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/28/2018

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/18/2018
• 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