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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-16
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
The device has been received; however, the cause of the reported event had not been determined because the evaluation has not been completed. Once the investigation is compete, a supplemental reported will be submitted with the results. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that when trying to exchange the microcatheter for post-dilation, the guidewire (gw) did not pass and the whole system was removed. The medtronic flow diverter delivery system was observed to be broken and adhered to the microcatheter tip. This event occurred during the treatment of an internal carotid artery-ophthalmic artery bifurcation, aneurysm that was unruptured. The distal landing zone was 3. 5mm and the proximal was 4. 5mm. The vessel tortuosity was normal.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
4775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
4775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9195091
MDR Text Key194480318
Report Number2029214-2019-01027
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 11/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-16
Device Lot NumberA836546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Yes
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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