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 Death (1802); Pain (1994); Sepsis (2067); Blood Loss (2597); Not Applicable (3189)

Event Type  Death  

Manufacturer Narrative

(b)(4).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 the ethicon product involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe that ethicon suture caused/ contributed to the neonatal death (due to prematurity and sepsis)? does the surgeon believe there was any deficiency with the ethicon suture products used in this procedure? citation: aus.Nz j obstet gynaecol 1997: 37: 4:407-411.(b)(4).

Event Description

It was reported via journal article: "title: treatment of cervical incompetence by transabdominal cervicoisthmic cerclage" author(s): simon craig, mbss and john r.H.Flieger, md citation: aus.Nz j obstet gynaecol 1997: 37: 4:407-411.This study aimed to present further evidence that transabdominal cervicoisthmic cerclage (tcc) has a confirmed role in obstetric management of a selected subgroup of women with cervical incompetence.Between 1987 and 1996, 12 female patients (mean age of 31 years [ranged from24-38 years]) underwent tcc.Cerclage was accomplished using mersiline tape (n=10) and mersilk (n=2) in posterior knot (n=4) or anterior knot (n=8).Insertion of the tcc was relatively uncomplicated.There were case of heavy bleeding during tcc.In case 2, a (b)(6) pregnant woman had tcc insertion experienced spontaneous rupture of membrane with chorioamnionitis at (b)(6) for which hysterotomy was performed.Twelve months later, the patient conceived and had spontaneous rupture of membrane with presumed chorioamnionitis at (b)(6) which she underwent caesarian section and had neonatal death resulted due to prematurity and sepsis.Two years later, this patient had ongoing pelvic pain for which tcc was removed.Transabdominal cervicoisthmic cerclage is a procedure with risk of morbidity which should not be undertaken lightly.However it has a definite place in the obstetric management of a subgroup of women with cervical incompetence.

Manufacturer Narrative

(b)(4).

• 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: 7694427
• MDR Text Key: 114184321
• Report Number: 2210968-2018-74436
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2018
• 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): Death