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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-500-16
Device Problem Activation Failure (3270)
Patient Problem Fistula (1862)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that 3 pipeline devices were lazy to open in the middle and distal segments and were recapture multiple times which did not resolve the issue. The devices were removed and subsequent devices used. The fourth device was used successfully but was also a bit lazy to open, and the proximal end was not completely opposed. After multiple attempts to cross into the device, it was found that a small fistula had formed, so another pipeline was used to cover the fistula which was implanted successfully and provided a satisfactory result. The patient was undergoing an unruptured, saccular aneurysm with a max diameter of 6mm and a neck width of 4mm. The devices were prepared as indicated per the ifu and the patient's vessel tortuosity was noted to be severe. The devices were placed in a bend in the middle section during deployment. Dual antiplatelet treatment was administered, the pru level was unknown. Post procedure angiographic results showed partial filling of the aneurysm.
 
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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 Key12036192
MDR Text Key262629962
Report Number2029214-2021-00752
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-16
Device Catalogue NumberPED-500-16
Device Lot NumberA875033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2019
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: 06/21/2021 Patient Sequence Number: 1
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