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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-14
Device Problems Wire (430); Break (1069); Fracture (1260); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2017
Event Type  Malfunction  
Event Description

Patient with l-ica supra-ophthalmic cerebral aneurysm. Intra-op fracture of pipeline device delivery wire, distal end. It fractured/broke into two pieces. Pipeline deployed proximal to aneurysm, with residual distal portion of delivery wire still present in patient s/p failed attempts at removal. Wire now crossing from distal l-ica through a-comm into r-ica distally. Used merit 3. 2 fr. En-snare device to attempt to snare pipeline. Exchanged to amplatz 7mm microsnare kit. Threader 1. 2mmx12mm pta balloon advanced over synchro 2 wire to pipeline system. Synchro wire out and ev3 marksman catheter and solitaire platinum device advanced as a unit. The 198 cm of 204 cm pipeline wire removed. Septer occlusion balloon advanced over syncro 2 guidewire - inflated trying to pull pipeline system back. The 4x8 trek balloon advanced over synchro 2 wire to pipeline. Inflations were unsuccessful. Used amplatz 4mm gooseneck system, specter xc 4x11 balloon.

 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC.
9775 toledo way
irvine CA 92618
MDR Report Key6841557
MDR Text Key84643084
Report Number6841557
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2017
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date05/23/2020
Device MODEL NumberPED-450-14
Device Catalogue NumberPED-450-14
Device LOT NumberA465049
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/28/2017
Event Location Hospital
Date Report TO Manufacturer08/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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