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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
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. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Diestro, j. D. B. , parra-farinas, c. , zetchi, m. A. , spears, j. , & marotta, t. R. (2020). The pop (pull on pipe) maneuver: a technical note for rescuing a prolapsed pipeline device. Journal of stroke and cerebrovascular diseases, 29(4), 104647. Doi: 10. 1016/ j. Jstrokecerebrovasdis. 2020. 104647. Medtronic received a report of ped braid movement after placement. The patient was undergoing treatment for a large cavernous internal carotid artery aneurysm. During the procedure, a 5x35mm ped was deployed from the cavernous ica (distal to the neck of the aneurysm) to the petrous ica. In the process of retrieving the flow diverter wire with the microcatheter, the ped was inadvertently pushed into the aneurysm. The resulting partial prolapse moved the proximal edge of the ped close into the aneurysm lumen. Pulling on the microcatheter over the microwire only partly reduced the degree of prolapse. The pop maneuver in which an addition ped is placed was then performed to restore the ped into its desired configuration. Final cerebral angiograms and cone beam ct demonstrated adequate positioning and wall apposition of both peds.

 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9496801345
MDR Report Key9927281
MDR Text Key195899940
Report Number2029214-2020-00335
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 04/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received03/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 04/06/2020 Patient Sequence Number: 1
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