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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-350-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
See manufacturer report # 2029214-2021-00781 for the catheter involved in this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that when the marksman catheter and pipeline stent were in place, angiography found bleeding. Finally, the blood vessel was closed.  the patient did not experience any injury, symptoms, or complications. The devices were prepared and flushed according to the instructions for use (ifu). The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the middle cerebral artery. The max diameter was 13mm, and the neck diameter was 24mm. The patient's vessel tortuosity was minimal/normal. The landing zone was 3. 4mm distal and 3. 6mm proximal. The access vessel was the femoral artery, which was 7mm in diameter. Dual antiplatelet treatment was not administered.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12076117
MDR Text Key265206518
Report Number2029214-2021-00782
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,Followup,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-350-35
Device Catalogue NumberPED-350-35
Device Lot NumberB177217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/28/2021 Patient Sequence Number: 1
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