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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-20
Device Problems Break (1069); Unintended Ejection (1234); Activation Failure (3270)
Patient Problem Fistula (1862)
Event Date 12/24/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a broken pipeline pushwire. The patient was being treated with flow diversion assisted coiling for an unruptured saccular aneurysm of the left anterior choroidal and left posterior communicating artery. The aneurysm max diameter was 10mm and the neck diameter was 4mm. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered. It was reported that all devices were prepared according to the instructions for use (ifu). The pipeline was being deployed and was anchored distally at the terminus of the internal carotid artery. The middle portion of the pipeline was positioned in a vessel bend. When the pipeline was 75% deployed and the microcatheter was between the anterior and posterior genu, it was noted that middle section of the pipeline was not opened well so wagging was performed. During the wagging, the pipeline deployed completely before the microcatheter was pulled back proximal so though the pipeline was deployed, it was not fully unsheathed, it was still within the sheath 3-4mm. Despite early deployment, the device was fully opened and appeared to be positioned well. While attempting to resheath the delivery system, the pushwire broke just proximal to the proximal marker. The distal delivery system from the proximal marker to the tip of the coil were still within the carotid and middle cerebral arteries (mca). Several attempts were made with 4mm and 7mm gooseneck snares but were unsuccessful. During attempts to snare the pipeline delivery system, a carotid cavernous fistula (ccf) was created. Finally, the 4mm gooseneck snare was taken distal to the tip coil and pulled back it the mca which successfully captured the tip coil. The delivery system was then removed by pulling it back thru the deployed pipeline and out through the guide sheath. Another pipeline was deployed to treat the ccf created by the snare during the recapture attempts. It was noted that there had been no significant resistance noted while advancing the pipeline through the microcatheter or during deployment. The wagging and loading of the system were necessary to help the pipeline gain apposition and open completely, especially around the anterior genu. The posterior genu was high and absorbing a lot of the motion during case which made the wagging and loading process more difficult. Post-operative angiography showed aneurysm stasis with good pipeline deployment x2. The ccf was still present but flow was slowed compared to when it had developed.
 
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Brand NamePIPELINE FLEX
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11118567
MDR Text Key225280974
Report Number2029214-2021-00011
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberB010750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2020
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: 01/05/2021 Patient Sequence Number: 1
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