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 Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446); 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.If further details are received at the 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 product (nurolon or vicryl suture) 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 product (nurolon or vicryl suture) involved? citation: j neurosurg.2015; 123 (6): 1476¿1479.Doi: 10.3171/2015.1.Jns142102.(b)(4).

Event Description

It was reported via journal article "title : reduced csf leak in complete calvarial reconstructions of microvascular decompression craniectomies using calcium phosphate cement" author: chikezie i.Eseonu, md, c.Rory goodwin, md, phd, xin zhou, bs, debebe theodros, bs, matthew t.Bender, md, dimitrios mathios, md, chetan bettegowda, md, phd, and michael lim, md citation: j neurosurg.2015; 123 (6): 1476¿1479.Doi: 10.3171/2015.1.Jns142102.This study evaluates the outcomes of postoperative csf leak and wound infection for patients undergoing a complete cranioplasty using calcium phosphate cement versus incomplete cranioplasty using polyethylene titanium mesh following a retrosigmoid craniectomy for microvascular decompression (mvd).The authors evaluated 211 cases involving patients who underwent first-time retro-sigmoid craniectomies performed by a single attending surgeon for mvd of the trigeminal neuralgia from october 2008 to june 2014.From this patient population, 111 patients (age: 51.2 years) underwent calvarial reconstruction after retrosigmoid craniectomy using polyethylene titanium mesh, and 100 patients (age: 52.5 years) had reconstructions using calcium phosphate cement.Intraoperatively, following the decompression of cranial nerve v, the dura was closed with nurolon 4-0 non-absorbable braided nylon suture (ethicon).If dural defects remained after attempting a primary closure, then a collagen dura substitute membrane was used to close the gaps by placing the dura substitute membrane over the dural opening and using nurolon 4-0 non-absorbable braided nylon suture (ethicon) to attach the membrane to the dura.A collagen matrix was placed over the dura, and evicel fibrin sealant (ethicon) was applied over the collagen matrix.In patients who underwent a biocompatible, porous polyethylene implant with embedded titanium mesh over the top of the calvarial defect, the cavity between the dura and the mesh was then filled with evicel fibrin sealant (ethicon).In both procedures, the area was then irrigated with normal saline, and a layered closure was performed using vicryl 0-0 and 3-0 synthetic, absorbable, copolymer sutures (ethicon) with a running nylon sutures used to close the superficial skin layer.In both groups, reported complications included csf leak or pseudomeningocele (n-5) which required treatment with acetazolamide in 2 patients, temporary lumbar drain in 2 patients, and surgical repair in the operating room in 1 patient and wound infection (n-5) which required surgical debridement in 3 patients, intravenous antibiotic treatment in 1 patient, and oral antibiotics in 1 patient.The calcium phosphate cement provides a viable alternative biomaterial for calvarial reconstruction of retrosigmoid craniectomy defects in patients who have an mvd.The application of this material provides a biocompatible barrier that reduces the incidence of post-operative csf leaks.

Manufacturer Narrative

Pc-(b)(4) date sent to the fda: (b)(4) 2018.It was reported that this device is not malfunction reportable.Therefore, this medwatch report 2210968-2018-76656 is not reportable.Additional information was requested and the following was obtained: response received from author: sorry, i thought i already emailed about this? someone emailed me about the fibrin glue.We also don¿t think the sutures were an issue.The ae¿s that we mentioned are normal complications of mvds and in fact our complication rates of mvds in the comparator arm are lower than the national average.

• 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: 7985342
• MDR Text Key: 124492081
• Report Number: 2210968-2018-76656
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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?: Yes
• Date Manufacturer Received: 10/20/2018
• 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