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 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 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 used in this procedure? citation: laryngoscope 122: november 2012; doi: 10.1002/lary.23524.(b)(4).

Event Description

It was reported via journal article: title: "retrosigmoid approach to cerebellopontine angle tumor resection: surgical modifications." author(s): selena e.Heman-ackah, md, mba, maura k.Cosetti, md, sachin gupta, md, john g.Golfinos, md, j.Thomas roland, jr., md.Citation: laryngoscope 122: november 2012; doi: 10.1002/lary.23524.This retrospective review aimed to present surgical modifications to the standard retrosigmoid approach that eliminate the need for cerebellar retraction for visualization of the cpa and utilized only native bone for reconstruction of the operative defect and describe the complication rates in association with this approach.Between sep2000 and dec2010, 197 patients (n=96 male and n=101 female) underwent retrosigmoid approach to cerebellopontine angle tumor resection.In the procedure, 4.0 nurolon suture was place through the anterior dura of the incision and secured to a previously created hole in the cortical mastoid bone to retract the dura and the sigmoid sinus anteriorly.Complication included wound infection (n=7) which was treated by removal of bone flap (n=5) and hardware, and conservative treatment (n=2).The use of autologous material in reconstruction may assist in the prevention of postoperative wound infection.The low rate of headache may be attributed to the replacement of the craniotomy bone plate at the conclusion of the procedure as well as a decrease in cerebellar edema secondary to a lack of retractor use in the above described approach.Csf leak is a commonly encountered complication of cpa surgery via the retrosigmoid approach.Csf leaks likely resulted from a communication between the intracranial cells in the region of the iac drill-out and the extracranial mastoid air cells.Perimeatal cells may communicate with air cell tracts in the petrous apex, peritubal region, perilabyrinthine region, or retrofascia region.Cerebellar dysfunction secondary to cerebellar injury intraoperatively is a well-documented potential complication of the retrosigmoid approach and may partially be attributed to excessive cerebellar retraction intraoperatively.This approach is a safe and effective modification of the traditional retrosigmoid approach, with a low rate of postoperative complication, and facilitated intraoperative exposure.

• 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: 7999583
• MDR Text Key: 124827390
• Report Number: 2210968-2018-76726
• 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
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: 10/11/2018
• 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