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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 PED2-500-18
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2020
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 device that failed to open at the distal end. The patient was being treated for an unruptured saccular aneurysm of the right internal carotid artery. Vessel tortuosity was normal. Dual antiplatelet (dapt) was administered. It was reported that the all devices were prepared and used per the instructions for use. However, when the pipeline was delivered, the distal end failed to open. Less than 50% of the pipeline was deployed when the failure occurred. The pipeline was resheathed less than or equal to 2 times. No additional steps were taken or devices used to attempt to open the pipeline. The pipeline was considered to be potentially damaged so it was resheathed and removed with the microcatheter. Another pipeline was used to complete the procedure. There was no patient symptoms or injury. Post-procedure angiographic images showed good results.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10819627
MDR Text Key217325432
Report Number2029214-2020-01116
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-18
Device Catalogue NumberPED2-500-18
Device Lot NumberB091410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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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