MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

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

Patient Problems Miscarriage (1962); 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.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (mersilene tape) 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: int j infertility fetal med 2013; 4 (1): 1-5.(b)(4).

Event Description

It was reported via journal article: title: "can we reduce fetal loss with second trimester miscarriages and very preterm births due to cervical incompetence in women with repeated failed vaginal cerclages and/or 'inaccesible' cervices?" citation: int j infertility fetal med 2013; 4 (1): 1-5.The objectives of the study was to assess the reduction in fetal loss following transabdominal cervicoisthmic cerclage done for repeated failed vaginal cerclages and/or inaccessible cervices.An observational study of 113 pregnancies in 90 women (age range: 26 to 30 years old) after transabdominal cervicoisthmic cerclage from january 1999 to december 2010 at fernandez hospital, hyderabad, andrha pradesh, india.During the procedure, a mersilene 5 mm tape (ethicon) with a swaged needle was used.The anterior leaf of broad ligament was pierced with the blunt needle and the tape was gently pulled through the paracervical space from anterior to posterior.The procedure was repeated on the other side.The tape was pulled tight around the cervix, and the ascending branches of the uterine arteries were palpated to confirm the presence of pulsations.Reported complications included rupture of membranes in the immediate post-operative period (n-1) which required removal of the mersilene tape through colpotomy and miscarriage on the day of surgery (n-1).It was reported that both events were considered to be procedure-related fetal losses in this series.Other reported complication included premature rupture of membranes (n-2) which required removal of the mersilene tape by colpotomy.The authors concluded that the transabdominal cervicoisthmic cerclage offers a high rate of fetal salvage in patients with extremely poor obstetric histories as a result of cervical incompetence, where vaginal cerclage is not possible or has repeatedly failed.The risk of procedure-related complications can be minimal in skilled hands.It is a specialized procedure for selected patients in whom it improves the perinatal outcome.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• 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: 8095967
• MDR Text Key: 128191505
• Report Number: 2210968-2018-77292
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention