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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-400-25
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2020
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 delivery system detaching after implanting the stent and punctured the microcatheter during removal. The patient was being treated for an unruptured saccular aneurysm of the right internal carotid artery ophthalmic segment. The aneurysm max diameter was 20mm and the neck diameter was 8mm. Vessel tortuosity was severe. It was reported that after the pipeline stent was released, the doctor was capturing the pushwire and realized the distal portion of the pushwire had broken. The entire system was removed together within the microcatheter. After removal from the patient, the doctor observed that the pipeline pushwire had punctured the microcatheter. The devices had been prepared and used per instructions for use. There was no harm or injury to the patient.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10123909
MDR Text Key196420370
Report Number2029214-2020-00521
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-25
Device Catalogue NumberPED2-400-25
Device Lot NumberA890631
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 Received06/02/2020
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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