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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 PED2-425-20
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported the physician information could not be provided due to restriction by privacy regulations. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the push wire was broken at the proximal hypotube near the wire weld when pipeline deployment was completed. It was noted that there was some resistance between the pipeline and microcatheter during delivery. The protective sleeve at the tip was also removed, and it was possible to resheath the pipeline despite a twist in the middle of the device. The broken portion of the pusher was retrieved using a gooseneck snare and the phenom microcatheter. An arteriovenous shunt occurred when collecting the remaining wire, so percutaneous transluminal angioplasty was performed with a balloon and the shunt was almost gone. The patient was undergoing treatment of an unruptured, saccular aneurysm of the right internal carotid-cervical spine with a max diameter of 16mm and a neck diameter of 5mm. The devices were hydrated and prepared per the ifu. It was noted that the patient's vessel tortuosity was moderate. Dual antiplatelet therapy was given but the pru level was unknown. Ancillary devices include a load master 8fr guide catheter.
 
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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 Key11108876
MDR Text Key225062191
Report Number2029214-2021-00003
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-425-20
Device Catalogue NumberPED2-425-20
Device Lot NumberA819169
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 Received03/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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