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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-350-18
Device Problem Activation Failure (3270)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 03/08/2021
Event Type  Injury  
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 could not be opened. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the c7 section of the internal carotid artery. The max diameter was 3. 3mm, and the neck diameter was 4mm. The patient's vessel tortuosity was moderate. The landing zone was 2. 8mm distal and 3. 5mm proximal. The access vessel was the femoral artery, which was 6mm in diameter. It was reported that the distal of the pipeline failed to open after being deployed. After it was retrieved, the angiogram showed that one blood vessel disappeared, and it could not be opened after being pulled out of the body. The pipeline was not placed in a bend, and more than 50% was deployed when it failed to open. The pipeline was resheathed 2 or less times, and no additional steps were taken to open the device. The pipeline and microcatheter were removed and replaced.  angiographic results post procedure were said to be good. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a 6f long sheath, navien 5f guide catheter, and marksman microcatheter. When asked to clarify the angiogram showed that one blood vessel disappeared, it was reported a blood vessel in the middle cerebral artery (mca), the contrast agent could not be filled to show. The blood vessel was in poor condition and the blood flow might have been blocked by the marksman. The pipeline had been withdrawn from the body and replaced by a conventional stent assisted coil embolization. The patient suffered a slight cerebral hemorrhage after the operation, and intervention treatment had been carried out.
 
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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 Key11562775
MDR Text Key242179993
Report Number2029214-2021-00337
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,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-350-18
Device Catalogue NumberPED-350-18
Device Lot NumberB120119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2021 Patient Sequence Number: 1
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