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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-400-20
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
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 pipeline pushwire separated during deployment. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery with a max diameter of 7. 88mm and a 3. 55mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered, but the specific pru level was unknown. It was reported that during delivery of the pipeline, the stent's tip opened well, the physician pulled back for positioning, and everything went smoothly. However, in the process of continuing deployment of the stent, it was found that the pushing rod was pushed to the distal side, but the stent was not deployed. The surgeon tried to retrieve and found there was no way to retrieve the stent. It was thought the pushwire might have separated. The stent was then withdrawn carefully together with the marksman microcatheter. It was stated there was friction/difficulty with both the pushing and withdrawal process, but clarified the statement was referring to the stent's non-response to the pushwire. A new marksman and pipeline were then used, and the procedure was completed smoothly. 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 showed no problems. Ancillary devices include a cook 6f, navien 6f 115, marksman, transend ex, microplex 10 5mm/15cm helical 10 regular;microplex 10 4mm/10cm helical 10 regular.
 
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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 Key10483721
MDR Text Key207188800
Report Number2029214-2020-00876
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberA990194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/10/2020
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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