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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-300-30
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
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 the tip end of the guide wire was broken. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in the left vertebral artery with an unknown max diameter and an unknown neck diameter. It was noted the patient's blood flow was unknown and vessel tortuosity was minimal. It was reported that after the ped was deployed, the tip end was normally opened, and the tip end of the guide wire was broken during the recovery and repositioning process. The pushwire was broken, as the tip coil was detached. The broken segment was able to be removed from the patient with the catheter. It was unknown how many times the pushwire was rotated to deploy the pipeline. No friction or difficulty was noted. The pipleine was removed from the patient. The pipeline and the accessory devices were prepared as indicated in the ifu. A dapt (dual antiplatelet treatment) was administered and the pru level was unknown. The angiographic result post procedure showed a slowed down blood flow. The issue was resolved with the explant. Ancillary devices include a 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12533242
MDR Text Key273388606
Report Number2029214-2021-01204
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-300-30
Device Catalogue NumberPED-300-30
Device Lot NumberB137459
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/22/2020
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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