MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE

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

Patient Problems Incontinence (1928); 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.No specific patient information regarding events 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 (prolift, monocryl suture or nurolon suture) used in this procedure? citation: ultrasound obstet gynecol 2014; 43: 365¿371.(b)(4).

Event Description

It was reported via journal article title: " comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized controlled trial." authors: k.Svabik, a.Martan, j.Masata, r.El-haddad and p.Hubka.Citation: ultrasound obstet gynecol 2014; 43: 365¿371.This single-center, randomized interventional trial aimed to compare the efficacy of two standard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion.From 2008 to 2011, 70 female patients who underwent surgery for pelvic organ prolapse were diagnosed with avulsion injury and were randomized into two groups: prolift group (n=36; mean age of 63.4 years [sd of 8.61 years]) and sacrospinous vagina colpopexy with native tissue vaginal repair (ssf) group (n=34; mean age of 62.5 years [sd of 10.85 years]).For the prolift total procedure, prolift total kit was used where mesh was inserted from the bladder neck and sutured to the vaginal apex using vicyrl plus 2.0 and attached posteriorly to the introitus; the vaginal wall was sutured with running monocryl 2.0 suture.In ssf, the anterior vaginal repair was done using vicryl plus 2.0 stitches; vicryl plus 1.0 was used in posterior high levatorplasty; the ssf procedure was performed unilaterally on the right using two permanent sutures of nurolon 1.0 (ethicon) inserted under visual control and attached to the vaginal apex.At 3-month follow-up, post-surgery outcomes included stress urinary incontinence (n=11 prolift group; n=3 ssf group); symptomatic prolapse recurrence (n=3 ssf group) which required reoperation with prolift total mesh (n=1), prolift anterior mesh (n=1) and prolift posterior mesh (n=1); minor mesh exposure (n=3 prolift group) which resected during tvt-o procedure in 2 patients and conservative treatment in one; and vaginal blood spotting due to granulation tissue (n=5 ssf group) treated on an outpatient basis.At 1-year follow-up, outcomes included clinical/ultrasound anatomical failure (n=1 prolift group, n=22 ssf group; n=1 prolift group; n=21 ssf group), stress incontinent (n=16 prolift group; n=10 ssf group), de novo incontinence (n=13 prolift group; n=3 ssf group), dyspareunia (n=2 prolift group; n=1 ssf group).In conclusion, ssf (vaginal sacrospinous colpopexy) in patients with prolapse after hysterectomy and avulsion levator injury has a higher anatomical failure rate compared with the prolift total procedure at 1-year follow-up.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 7855565
• MDR Text Key: 119639425
• Report Number: 2210968-2018-75700
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2018

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
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/07/2018
• 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