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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 PED2-350-12
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
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 two pipeline devices moved during deployment and could not be resheathed into the phenom 27 microcatheter. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left posterior communicating artery. The max diameter was 4mm, and the neck diameter was 2mm. The patient's vessel tortuosity was normal. The landing zone was 2. 91mm distal and 3. 50mm proximal.  dual antiplatelet treatment was administered, and the pru level was 161. It was reported that the phenom 27 catheter was advanced into distal m1. During deployment the pipeline device fell back proximal to desired landing zone. The doctor attempted to resheath the device, and it got stuck in microcatheter and she was unable to resheathed. Multiple attempts were made. The guide catheter was advanced and the phenom catheter was manipulated. The doctor was still unable to resheath the pipeline. The pipeline was not deployed and removed from the patient. Another pipeline was used, and during deployment the same issue occurred with the second device. The pipeline was partially open but not deployed and the system fell back proximal to aneurysm neck. The doctor attempted to resheath the device and it was stuck in the phenom catheter. Multiple attempts were made to resheath the device again, and all attempts were unsuccessful. This device was also removed from the patient. Finally, a third pipeline was deployed without incident. There was no injury to the patient and a good angiographic result was achieved post procedure. There was no damage to the pipeline pushwire.  the devices were prepared according to the instructions for use (ifu). Ancillary devices include a benchmark 105 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12294927
MDR Text Key265618399
Report Number2029214-2021-00992
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-350-12
Device Catalogue NumberPED2-350-12
Device Lot NumberB190138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2021
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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