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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-25
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem Stenosis (2263)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline pushwire that was stuck during retraction through the microcatheter and was found to be broken. The patient was being treated for an unruptured saccular aneurysm of an ophthalmic artery segment. The aneurysm max diameter was 2mm and the neck diameter was 1mm. Vessel tortuosity was normal. It was reported that all the devices in the procedure were prepared as indicated in the instructions for use (ifu). After implantation of the pipeline, the delivery wire could not be retrieved through the microcatheter. The entire system was removed together and it was found that the wire was broken at the proximal end developing point. Post-operative angiography revealed slow blood flow but no harm or injury to the patient.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10321150
MDR Text Key200872331
Report Number2029214-2020-00725
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-25
Device Catalogue NumberPED-425-25
Device Lot NumberA890614
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 Received07/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/29/2019
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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