MAUDE Adverse Event Report: ETHICON INC. SURGICEL NU KNIT HEMO 7.5X10; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Type of Reportable Event	Serious Injury
Additional 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? citation: world neurosurg.(2019) 127:160-164.(b)(4).
Event or Problem Description
It was reported via a journal article: a rare case of postoperative symptomatic cyst formation after resection of a large convexity meningioma takeshi fujimori, atsushi shindo, daisuke ogawa, masaki okada, tetsuhiro hatakeyama, masanobu okauchi, masahiko kawanishi, keisuke miyake, takashi tamiya world neurosurg.(2019) 127:160-164.Background: symptomatic cyst formation after brain tumor resection is a rare complication of the early postoperative phase.We describe a complicated case of postoperative symptomatic cyst formation after gross total removal of a convexity meningioma.Case description: a (b)(6) year-old woman presented with recent onset motor aphasia.Magnetic resonance imaging revealed a left convexity tumor.We performed gross total resection of the tumor, which was pathologically diagnosed as an atypical meningioma.An absorbable hemostat was placed over the surface of the tumor cavity.Tumor resection and decompression of the normal cerebral hemisphere improved aphasia.However, 3 days after surgery, her motor aphasia worsened.Computed tomography scan confirmed that the frontal lobe was being compressed by an enlargement of the postoperative tumor cavity.Conservative therapy did not shrink the cavity, and her motor aphasia persisted.Therefore, 21 days after surgery, a drainage tube was inserted into the enlarged cavity using a neuroendoscope, which promoted shrinkage of the cavity and improved her motor aphasia.We suspected that the enlargement of the postoperative cavity was because of the presence of a valve-like structure.Conclusions: even though formation of symptomatic cystic lesions after brain tumor resection is rare, neurosurgeons should be aware of such early postoperative complications and their management strategies.

• Brand Name: SURGICEL NU KNIT HEMO 7.5X10
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8842486
• Report Number: 2210968-2019-84673
• Device Sequence Number: 372199
• Product Code: LMG
• UDI-Device Identifier: 10705031002975
• UDI-Public: 10705031002975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR