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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-20
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. The device involved in this event is not approved in the us; the device's brand name and model number are provided below. This report is being filed against a similar device, which is provided in brand name: pipeline flex with shield technology model number: ped2-400-20. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was deployed with no concerns. The tip coil was retrieved with the microcatheter per the ifu into the distal access catheter, and the microcatheter removed for final dsa run during which something was noted to travel forward. Imaging showed the tip coil sitting at the base of the cavernous carotid segment, which was subsequently received with a stent. A second photo showed what appears to be the wire snapped off just proximal to the resheathing pad. There were no further complications. Post procedure angiographic results were good. The vessel was normal tortuous.
 
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Brand NamePIPELINE FLEX 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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8810181
MDR Text Key151713259
Report Number2029214-2019-00767
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 07/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2022
Device Model NumberPED-400-20
Device Lot NumberA772796
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 Received06/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/26/2019
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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