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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 PED2-500-30
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
Physician is not provided based on country privacy laws. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding difficulty with positioning of a pipeline device and failure of the middle segment to open. The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of an internal carotid artery (ica) c3 segment. The aneurysm max diameter was 11. 42mm and the neck diameter was 4. 2mm.  the blood vessel diameter of m1 was about 3mm, and the blood vessel diameter from the internal carotid (ic) top to the ophthalmic artery was about 4mm. Vessel tortuosity was moderate. It was reported that the pipeline flex with shield was prepared according to the instructions for use (ifu). An attempt was made to deploy the ped in the m1 but the deployment was insufficient. As the microcatheter was repeatedly raised and lowered from the sleeve to the middle of the pipeline, the distal end developed a trumpet shape and the middle section did not open at all. It was thought the device was possibly damaged so it was retrieved and replaced with a different lot. However, the replacement pipeline also had difficulties with deployment resistance with the sleeve. It was considered that the pipeline size might not be correct so the device was resheathed to retrieve. During retrieval, the pushwire broke so the device and microcatheter were removed together. Another device was used to complete the event. There was no harm or injury to the patient. Post-operative angiography was normal.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12389200
MDR Text Key271646356
Report Number2029214-2021-01088
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-30
Device Catalogue NumberPED2-500-30
Device Lot NumberB049761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
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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