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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-021-350-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 05/20/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient experienced interim muscular haematoma at the right radial access site and hospitalized from (b)(6) 2021 to (b)(6) 2021. Treatment consisted of monitor wound site, ceased heparin infusion, and a blood transfusion. The adverse event was resolved on (b)(6) 2021. There was no device malfunction reported as a part of the event. The patient was undergoing surgery for treatment of a saccular aneurysm of the right posterior communicating (pcom) artery with a max diameter of 2. 4 mm and a 2 mm neck diameter. The site assessment deemed the adverse event to have a causal relationship with the underlying condition/disease and not related to the device, drug, or procedure. However, the sponsor assessment related the event to the procedure.
 
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Brand NamePIPELINE VANTAGE WITH 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12108895
MDR Text Key259676086
Report Number2029214-2021-00810
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-021-350-12
Device Catalogue NumberPED3-021-350-12
Device Lot NumberB152179
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 Received09/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/27/2021
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: 07/02/2021 Patient Sequence Number: 1
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