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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 PED2-475-20
Device Problems Unintended Ejection (1234); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
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 physician started to unsheath the pipeline stent, but then the stent was resheathed for repositioning. During the second unsheathing, it was noticed the distal part of the stent seemed twisted, and the edge of the stent looked folded. An attempt to resheath the stent was made when the tip coil appeared inside the stent. The stent detached from the delivery wire, and the proximal segment of the stent was stuck inside the microcatheter only. Due to the incomplete deployment and twisted distal portion, the physician carefully handled the microcatheter until deploying the stent in totality. However, the distal part of the stent was not well accommodated. An atlas stent was implanted to telescope the pipeline in order to open the distal segment well. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results were good. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery (ica) with a max diameter of 5 mm. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unavailable.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12099585
MDR Text Key259401973
Report Number2029214-2021-00800
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P100018 S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberA915540
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 Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2019
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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