MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spontaneous Abortion (4514)

Event Date 10/22/2022

Event Type  Injury  

Event Description

Title: monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (c-stich): a pragmatic randomised, controlled, phase 3, superiority trial.The aim of this study was to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.Between aug 21, 2015, and jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024).The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group.Only the suture material was prespecified as per the randomised allocation.Where possible, use of mersilene (ethicon, raritan, nj, usa; non-absorbable and composed of polyethylene terephthalate) was encouraged for the braided suture and ethilon (ethicon; non-absorbable and composed of longchain aliphatic polymers of nylon) was encouraged for the monofilament suture.Reported complications included braided suture group insertion complication (bleeding from the cervix.Suture removal complications, maternal sepsis, chorioamnionitis.Monofilament suture group had ruptured membranes during cervical cerclage insertion, maternal sepsis, chorioamnionitis and pregnancy loss and infection.In conclusion trial aimed to establish whether the use of a monofilament suture material was superior to a braided suture material when performing a vaginal cervical cerclage for the prevention of pregnancy loss.The hypothesis of the trial was that braided sutures would harbour bacteria predisposing to infection, pregnancy loss, and premature birth.In conclusion, our results found no evidence of differences in rates of pregnancy loss between the suture groups.Clinicians should consider using a monofilament suture thread when performing a vaginal cervical cerclage, to reduce the risk of maternal sepsis and chorioamnionitis, due to the association of chorioamnionitis with adverse maternal outcomes.13 clinicians caring for women offered a vaginal cervical cerclage should use the result of this trial to facilitate discussions around the suture thread to optimise outcomes.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-00104, 2210968-2023-00106.Citation: lancet 2022; 400: 1426¿36.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16104505
• MDR Text Key: 306727591
• Report Number: 2210968-2023-00105
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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