MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT; HEMOSTATIC AGENT, ABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Fistula (1862); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The events were reported through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.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?.

Event Description

It was reported in a journal article entitled: randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty authors: eduardo vieira, md, thiago c.Guimarães, md, igor v.Faquini, md, jose l.Silva jr., md, tammy saboia, md, rodrigo v.C.L.Andrade, md, thaís l.Gemir, md, valesca c.Neri, md, nivaldo s.Almeida, md, and hildo r.C.Azevedo-filho, msc, phd, frcs citation: published online november 17, 2017; doi: 10.3171/2017.4.Jns152954.The objective of this clinical article was to conduct a prospective randomized controlled trial comparing 2 techniques for performing decompressive craniectomy (dc): with watertight duraplasty and without watertight duraplasty (rapid-closure dc).Of the remaining 55 patients, 28 were assigned to the control group (with duraplasty/ watertight closure) and 27 to the test group (without duraplasty/rapid-closure dc).From january 2012 to december 2013, patients with age ranging from 18 to 60 years old undergoing dc were included in the study.During the procedure after dural opening, watertight duraplasty with pericranium or an artificial graft (at the surgeon¿s discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, in which the exposed brain parenchyma was covered with surgicel.Usual closure was then performed.Two patients in each group developed a csf leak.Three of the patients were treated conservatively with acetazolamide and/or lumbar csf drainage, while 1 patient (in the control group) required surgery for correction.One patient in each group developed wound infection and both were treated surgically.Two patients in the control group and 1 patient in the test group developed subgaleal fluid collection seen on postoperative ct scans.These collections were probably caused by csf leakage through duraplasty or opened dura but contained by the skin closure.Patients were asymptomatic and required no treatment.In conclusion, dc without watertight duraplasty was not associated with a higher incidence of postoperative complications (i.E., csf leaks, wound infections, abscesses, and subgaleal collections) and decreased surgical time by 31 minutes on average, which can be beneficial in critically ill patients, especially in victims of severe tbi.Additional information has been requested.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT
• Type of Device: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7617824
• MDR Text Key: 111649597
• Report Number: 2210968-2018-73573
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention