MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

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

Patient Problems Paresis (1998); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product 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 used in this procedure? patient demographics: (b)(4).

Event Description

It was reported via a journal article: title: acute monocular blindness due to orbital compartment syndrome following pterional craniotomy author/s: jeroen g.V.Habets1, roel h.L.Haeren1, suen a.N.Lie2, noel j.C.Bauer3, jim t.A.Dings1 citation: world neurosurg.(2018) 114:72-75; doi: https://doi.Org/10.1016/j.Wneu.2018.03.013.This case report aimed to present a (b)(6) female patient who had aneurysm underwent anterior communicating artery clipping via a pterional approach.In the procedure during the closure of wound, the dural incision was sutured in a watertight fashion covered with tachosil, fibrin sealant patch and surgicel.Four days after the procedure, she developed proptosis, severe ocular movement paresis, and subjective visual impairment of her right eye.A ct scan of the brain and orbita revealed an intraorbital extraconal collection located nearby the orbital roof defect compromising the superior oblique muscle and optical nerve.An urgent recraniotomy was performed in which no active cerebrospinal fluid leakage from the dural incision was noted and the dura located around the orbital roof defect was intact.The intraorbital collection appeared as a csf collection and was evacuated.Thereafter, the osseous defect was covered with tachosil, fibrin sealant patch and surgicel.The dural incision was resealed with tachosil fibrin sealant patch to prevent recurrence of csf leakage.Directly postoperative, proptosis was diminished but visual acuity was subjectively unchanged.The following day, proptosis increased and va was 2/300 in the right eye.A repeated cerebral ct scan showed a remaining but smaller intraorbital csf collection.A blunt dissection was carried out in which a clear csf collection was drained, leading to immediate reduction of proptosis.No drain was placed and an external lumbar csf shunt and acetazolamide were introduced for 12 days.Proptosis did not recur, and ocular movements improved.Nevertheless, va was 2/60 and vision was limited to light perception at discharge.The ophthalmologist concluded there was irreversible vision loss.Hospital stay was further complicated by delirium.At 3 months¿ follow-up, vision of the right eye did not improve further than minimal light perception.A causal role of the orbital roof defect, caused by surgical drilling, is suggested in our case since the intraorbital csf collection was located near the defect.Because no local dural tear was noted near the orbital roof defect, csf forming the collection in our case probably leaked from the dural incision.Any dural defect near an orbital defect should be closed meticulously, and external drainage of csf could be considered to prevent occurrence of an intraorbital csf collection.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9177682
• MDR Text Key: 162644924
• Report Number: 2210968-2019-88556
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

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: 09/12/2019
• Initial Date FDA Received: 10/10/2019
• 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
• Patient Age: 65 YR