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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
Model Number PED-425-16
Device Problems Break (1069); Unintended Ejection (1234); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline became locked up in the distal segment of the phenom 27 microcatheter and became dislodged from the pushwire. The patient was undergoing surgery for treatment of three aneurysms: saccular, unruptured aneurysms in the ica terminus; supraclinoid; and ophthalmic segement. Max diameters were estimated: terminus 5 mm. Superclinoid 4 mm. Opthalmic 7 mm, and neck diameters were estimated: terminus 3. 5 mm. Superclinoid 3 mm. Opthalmic 4 mm. It was noted the patient's vessel tortuosity was moderate. It was reported that the first pipeline was implanted covering the left ica terminus and supraclinoid aneurysms. The the physician advanced the phenom 27 catheter through the implanted pipeline, followed by a second pipeline into a straight segment of the m1. The distal 20% of the pipeline (ped) was opened, and then the physician attempted to recapture the ped using varying degrees of force but was unable to. About 10% more of the ped was let out, and then pulled back on the entire system to relax any forward tension. During the next recapture attempt, the ped became dislodged from the pushwire. The physician could freely advance the pushwire without response from the ped. Then the ped was pulled through the vessel into the guide catheter. The ped, pushwire, and phenom 27 were all successfully removed from the patient. There was no visible damage to the pushwire or ped, but an accordion style damage to the distal segment of the catheter. A new phenom 27 and ped were used to complete the procedure with no issue. It was noted prior too ped implantation, the guide catheter was used which moved frequently in a moderately tortuous area between anterior and posterior genus which required frequent repositioning. Ancillary devices include a penumbra benchmark catheter, phenom 27 microcatheter.
 
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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 Key9700354
MDR Text Key189076967
Report Number2029214-2020-00139
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 05/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model NumberPED-425-16
Device Catalogue NumberPED-425-16
Device Lot NumberA556725
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 Received05/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/15/2017
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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