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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 PED2-500-20
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
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 distal end of the pipeline opened, but then dog boned in the middle section while the rest of the device continued to open. An attempt was made to recapture and reopen was performed once, but with no success. It was noted the device was not positioned in a bend, more than 50% of the device had been deployed when it failed to open, and no additional steps were taken to open the device. The procedure was completed with no issues by using another pipeline device. 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. The patient was undergoing surgery for treatment of asaccular, unruptured aneurysm of the paraopthalmic internal carotid artery. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. Ancillary devices include a fubuki 8f, via 27, synchro 14.
 
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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 Key10580543
MDR Text Key208346038
Report Number2029214-2020-00966
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-20
Device Catalogue NumberPED2-500-20
Device Lot NumberB019200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/04/2020
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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