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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-20
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
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 part of the pipeline pushwire broke. The patient was being treated for an unruptured, saccular aneurysm of the right ica. The max diameter and neck diameter were 3 mm. Dapt was administered and pru level was 170. Patient vessel tortuosity was minimal. The landing zone was 3. 9 mm distal and 4. 2 mm proximal. The phenom 27 was navigated to the desired location. The physician deployed the pipeline with no problem. While trying to retrieve the ped pushwire using the phenom 27 in order to finish the procedure, the physician said they felt a little tension and they said they felt something broke. This occurred when he was resheathing the distal tip of the pushwire inside the phenom 27. The angiographic images didn't show any fracture. The physician removed the pushwire as usual, with no additional maneuvers required and with no complications. Once the phenom 27 and the pushwire were out of the patient, the physician noticed the fracture of the distal portion of the pushwire (close to the resheating pad). There was friction/difficulty during retrieval, but it was said to be minimal. The pushwire segment was removed with the catheter and the procedure was completed successfully. All devices had been prepared and the catheter flushed per the instructions for use (ifu). There was no harm or injury to the patient. Post-procedure angiographic results were normal. Ancillary devices include a nueron max 088 sheath and phenom 27 microcatheter.
 
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Brand NamePIPELINE FLEX
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 Key11114599
MDR Text Key225062970
Report Number2029214-2021-00008
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P100018.S011
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 01/04/2021
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 Expiration Date04/25/2022
Device Model NumberPED-425-20
Device Catalogue NumberPED-425-20
Device Lot NumberA821514
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 Received12/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/26/2019
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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