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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-475-14
Device Problems Break (1069); Activation Failure (3270)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/27/2019
Event Type  Injury  
Manufacturer Narrative
The remainder of the pushwire has been returned; evaluation is in progress. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report of pipeline flex wire fracture. During the procedure, the pipeline flex device was partially deployed into the right mca and then retracted into predetermine distal zone, just proximal to the anterior choroidal artery. The pipeline was then deployed into the anterior genu without complication. There was moderate manipulation done to the proximal portion of the device in the distal landing zone to get it to open fully. Device was then fully deployed and the catheter was tracked back over the device wire for recapture. The proximal portion of the device caught and pushed 2mm distal, but the device looked good and well opposed otherwise. At some point the distal portion of the pipeline wire broke off into the catheter and was then pushed out into the artery. The treating physician then snared the distal portion, but the wire slipped off while retrieving and stents were then used to pin the wire to the vessel wall. The broken distal section was left in the right ica, proximal to the pipeline. The patient remained asymptomatic. The post procedure angiographic was clean a no deficits noted. The treating location was the right ica, ophthalmic region. The aneurysm was unruptured and saccular. The max diameter was 5. 5mm and the neck was 3. 5 mm. The distal landing zone was 3. 8mm and the proximal was 4. 75mm. The vessel anatomy was moderate in tortuosity.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9508527
MDR Text Key178532096
Report Number2029214-2019-01284
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
Report Date 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-14
Device Lot NumberA880359
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2019
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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