MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Lot Number UNKNOWN

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 09/10/2016

Event Type  Injury  

Manufacturer Narrative

Date of conference p-288 cirse 2016 posters comparison of embolization protection devices with proximal balloon device and -filter device: procedural complications and embolic infarctions on dwi m.H.Rho, h.P.Hong radiology, kangbuk samsung hospital, sungkunkwan university school of medicine, seoul, korea.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Purpose: proximal balloon-type embolization protection device (epd) and distal filter-type epd have been used during cas.This study compares the related complications and thromboembolic infarctions on diffusion weighted image (dwi) encountered using these two types of epds.Material and methods: a retrospective review of 103 patients undergoing cas using a balloon occlusion epd (moma) or filter epd (spider fx, filterwire) was conducted.Symptomatic stenosis, degree of stenosis, site of stenosis, ulceration, and collateral status were evaluated.Complications and technical, reversible, and neurological compromises during epd deployment were assessed.Procedure time, new infarctions on dwi after cas (tiny: <(><<)>3 mm, small: <(><<)>10 mm, medium: <(><<)> 20 mm, and large: >20 mm), and 30-day clinical results after cas also were evaluated.Results: symptomatic and asymptomatic complication rate was slightly higher in the moma group (20%) compared with the spider group (15%), and in-stent thrombosis with near complete and complete occlusion was noted in two patients in the moma group during the procedure.New tiny infarctions on dwi were higher in the spider group compared with the moma group (p <(><<)>.05).The 30-day stroke rate was 2.3% in the balloon group (n_ =_ 43) and 3.3% in the filter group (n_=_ 60, p <(> <<)>.05).Technical difficulties included a 10% incidence of intolerance during balloon deployment compared with 0% in the filter group (p =.043).Conclusion: both balloon occlusion and filter devices provide acceptable results with similar complication rates and clinical results.Although filter showed higher new tiny infarctions than balloon occlusion, this device can be used preferentially to avoid a 10% incidence of intolerance associated with balloon occlusion and 4.7% incidence of in-stent thrombosis.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6329069
• MDR Text Key: 67377580
• Report Number: 2183870-2017-00069
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111010
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2017
• 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