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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 LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-300-12
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that the pipeline was implanted with no issues reported. The last angiography post-procedure looked okay. However, the mri the next day showed the pipeline looked positioned half in the aneurysm and half deployed in the internal carotid artery. It was noted the device may have been too short. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the anterior choroidal artery with a max diameter of 2. 78 mm and a 3 mm neck diameter. Ancillary devices include a phenom27.

 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceLASER THERAPY PRODUCT
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 Key10558185
MDR Text Key207717493
Report Number2029214-2020-00949
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
Report Date 10/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/20/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED2-300-12
Device Catalogue NumberPED2-300-12
Device LOT NumberA659369
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 Received09/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/12/2018
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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