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 Wound Dehiscence (1154); No Code Available (3191)

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.Citation: neurosurgery.2012; 71 (2): 302¿307.Doi: 10.1227/neu.0b013e31826a8ab0.(b)(4).

Event Description

It was reported via journal article title: "augmented autologous pericranium duraplasty in 100 posterior fossa surgeries¿a retrospective case series," authors: fred c.Lam, md, phd, ekkehard kasper, md, phd.Citation: neurosurgery.2012; 71 (2): 302¿307.Doi: 10.1227/neu.0b013e31826a8ab0.The objectives of the study was to report our experience using locally harvested autologous pericranium as a dural substitute in patients who underwent p-fossa surgeries.This is a retrospective analysis of 100 patients (43 male and 57 female patients; age range: 22 to 94 years old) who had undergone p-fossa craniotomies between 2005 and 2011.During the surgical procedure, following the bony decompression and durotomy, the pericranium is shaped to the dural defect and sutured in by the use of nurolon 4-0 running braided silk (ethicon), applied meticulously under the operating microscope or loupes magnification.This patch is then patted dry by a sponge and covered with 1 layer of surgicel (ethicon) which is spray covered with dural sealant or evecil (ethicon) to augment the watertight closure.Each closure was tested intraoperatively pre and post sealant application with a valsalva maneuver.If no fluid leak was observed, the case was closed in a routine fashion by applying a layer of thrombin-soaked surgifoam (ethicon) with or without subsequent cranioplasty, finally followed by a multilayer closure of the soft tissues.Reported complication included dehiscence in the center of the graft (n-1) which required surgical repair.Autologous pericranium with dural sealant augmentation is an effective way to repair the durotomy in p-fossa surgeries.This is currently the largest study using this technique in the adult neurosurgical literature.The results reported a much lower rate of complications in comparison with other duraplasty studies.

• 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: 8025872
• MDR Text Key: 125706019
• Report Number: 2210968-2018-76860
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• 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
• Treatment: SURGICEL, EVICEL, SURGIFOAM
• Patient Outcome(s): Required Intervention