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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-18
Device Problem Break (1069)
Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654); Foreign Body In Patient (2687); Vascular Dissection (3160)
Event Date 11/18/2020
Event Type  Death  
Manufacturer Narrative
Regarding entry to follow-up - the event is reportable for malfunction of a device not distributed in the united states but similar to devices distributed in the us. The patient died and as such the report could not be submitted unless type of report was marked as "death". If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline pushwire which broke leading to additional intervention. The patient died the following day. The patient was being treated for an unruptured saccular aneurysm of the left internal carotid artery ophthalmic segment. The aneurysm max diameter was 6mm and the neck diameter was 5mm. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline and all accessory devices were prepared and used per the instructions for use. The pipeline was de livered to the intended location and opened adequately. However, at that point the distal tip of the pipeline pushwire broke off and remained in the patient. The surgeon used a 4mm snare to attempt to retrieve the pushwire fragment without success. After initial attempts to capture the pushwire fragment failed, the surgeon performed a dissection of the other end of the cerebral artery to attempt to access and retrieve the pushwire fragment. Due to the additional puncture of the artery at that site, the patient had bleeding and received treatment to reverse the effects of the heparin. The surgeon waited for bleeding to stop. A balloon was used at the pipeline location to accommodate access to the location of the fragment. Then the surgeon again attempted to retrieve the pushwire fragment from the artery puncture site several times without success. It was then decided to leave the wire fragment within the patient and end the procedure. Post-procedure angiography showed adequate opening of the pipeline with the broken pushwire tip located in the cavernous segment of the carotid artery up to the middle cerebral artery. Later on the night of the procedure the patient had a cardiac arrest. The physician believed the patient had developed a thrombus in the artery. The patient died the following day, (b)(6) 2020. Ancillary devices: neuron max 088 sheath, neuron 053 guide catheter, marksman microcatheter used to deliver the pipeline, rebar-18 microcatheter was used with the snare, avigo guidewire, 4mm microsnare.
 
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Brand NamePIPELINE FLEX W/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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10871934
MDR Text Key217292719
Report Number2029214-2020-01155
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-18
Device Catalogue NumberPED2-475-18
Device Lot NumberA858341
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 Received11/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/02/2019
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: 11/19/2020 Patient Sequence Number: 1
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