MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CLIP - EXACT CODE UNKNOWN; CLIP, IMPLANTABLE

Catalog Number CLIPXX

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

Patient Problems Edema (1820); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: publication year for the journal article is 2018.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

It was reported that during review of journal article, title : growth of thrombosed cerebral venous varix following resection of cerebral arteriovenous malformation: case report with pathologic consideration.Author : shinya haryu, hidenori endo, toshiki endo, kenichi sato, miki fujimura, teiji tominaga.Citation: world neurosurg.(2018) 119:274-277.The purpose of this case report was to show the growth of a thrombosed cerebral venous varix in the drainage route despite complete resection of the cerebral arteriovenous malformations (avm).This is regarding a (b)(6) man presented with transient aphasia.Magnetic resonance imaging (mri) and digital subtraction angiography revealed an avm with a maximum diameter of 30.2 mm in the left temporal lobe and was accompanied by a large venous varix with a maximum diameter of 40.3 mm in the superficial drainage route.Surgical resection was performed after arterial embolization.The large cerebral venous varix on the superficial drainage route was not resected as it was buried in the temporal lobe of the dominant hemisphere and could contribute to normal venous drainage.The venous varix was closed by ligation using titanium ligaclip (ethicon) and prolene nylon thread (ethicon).Postoperative mri showed thrombosis of the residual varix.Mri performed 5 months after the surgery revealed enlargement of the varix and emergence of perilesional cerebral edema.The thrombosed venous varix, which adhered to the surrounding dura mater, particularly at the site of ligation, was excised by reoperation to prevent further growth.Postoperative course was uneventful, and postoperative mri showed rapid improvement of the perilesional cerebral edema.Histologic evaluation showed thrombus inside the varix, which was surrounded by thick fibrous connective tissue.The thrombosed venous varix did not shrink but enlarged with the emergence of perilesional cerebral edema.One of the possible explanations for this phenomenon is reaction against a foreign body.Metallic materials, in addition to the wooden foreign bodies and cotton sheets, can cause intracerebral granuloma.

• Brand Name: CLIP - EXACT CODE UNKNOWN
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9549381
• MDR Text Key: 188494763
• Report Number: 3005075853-2020-00068
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLIPXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention