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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-NV-RFX
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Daniel a tonetti, shashvat m desai, stephanie casillo, benjamin m zussman, ashutosh jadhav, brian thomas jankowitz, tudor g jovin, bradley a gross. Stentriever salvage after failed manual aspiration thrombectomy. Doi:10. 1136/neurintsurg-2019-014828 medtronic literature review found a report of patient complications after during the use of the navien catheter. The purpose of the study was to identify predictors of successful crossover to smat (stent retriever mediated aspiration thrombectomy) after failed first pass mat (manual aspiration thrombectomy). Of 433 patients undergoing large vessel intracranial thrombectomy during the study period, 319 consecutive patients underwent first pass mat for lvo. Mean age was 71. 4 years and 52. 4% were women. One of six aspiration catheters were used for the initial clot in this study: the ace 60, 64, or 68 reperfusion catheter (penumbra inc), the sofia plus (microvention, aliso viejo, california, usa), axs catalyst 6 distal access catheter (stryker neurovascular), and the 6 f 0. 072 inch navien intracranial support catheter (medtronic, irvine, california, usa). It is unclear whether the 18 complications reported were involved with the manufacturer's device. - there were 13 instances of vessel perforation; two of these occurred in patients who underwent smat, yielding an overall 3% rate of perforation for those patients undergoing smat and a 4% rate for those with mat only (p=1).

 
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Brand NameREFLEX CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9484126
MDR Text Key209174945
Report Number2029214-2019-01256
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 12/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK-NV-RFX
Device Catalogue NumberUNK-NV-RFX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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