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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 PED2-475-35
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2020
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 segment of the pipeline did not open. Resheathing and redeployment were performed less than three times, but the stent still failed to open. It was noted the device was not in a bend, more than 50% had been deployed, and no additional steps were taken in an attempt to open the device. The pipeline was thenretrieved from the patient, but during retrieval, there was resistance in the proximal part of the phenom microcatheter. The physician did not want to risk losing the catheter position because it took a long time to reach the target position. The catheter was cut where the resistance was occurring, and the pipeline and catheter segment were then removed. With a change wire 300 mm, the physician was able to keep the position, and a new phenom 27 and pipeline were used to continue the treatment with a successful result. 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 angiography showed everything was fine. The patient was undergoing surgery for treatment of ruptured, carotid dissection on both sides followed by a dual fistula on both sides due to a bicycle accident. Ancillary devices include a cerenovus 8f guidecatheter, sofia dac 125 cm, phenom 27, headway 21, syncro standard 0. 014", synchro 10.
 
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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 Key10574992
MDR Text Key208346216
Report Number2029214-2020-00960
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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 Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2021
Device Model NumberPED2-475-35
Device Catalogue NumberPED2-475-35
Device Lot NumberA623127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/03/2018
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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