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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Muscle Weakness (1967); Stenosis (2263)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that was damaged at the distal end and then detached within the phenom microcatheter during retrieval. The patient was being treated with flow diversion for an unruptured saccular aneurysm of a paraophthalmic artery. The aneurysm max diameter was 8mm and the neck diameter was 6mm. Patient vessel tortuosity was moderate. It was reported that the devices were prepared and the catheter flushed per the instructions for use (ifu). The microcatheter was navigated to the m1. The pipeline stent was being deployed using the drag and drop technique. When going through the bifurcation into the interior carotid artery (ica) the pipeline came out too quickly and was too close to the distal neck of the aneurysm. The surgeon resheathed the stent and navigated back to the middle cerebral artery (mca) to reattempt stent deployment. However, during the second attempt, the distal tip of the stent had a folded shape as if it had folded over on itself. Upon advisement from the manufacturer representative (rep) the surgeon resheathed the stent to remove and replace. When retrieving the stent back through the microcatheter, the stent detached from the pushwire and was stuck within the catheter so the system was all removed together. After removal, it was noted that the pipeline ptfe sleeves were missing from the deployment wire. Nothing could be seen remaining in the patient on angio. A second pipeline was deployed successfully with good vessel wall apposition. On day two post-op, stenosis in the implanted stent was noted. The surgeon successfully retrieved the clot. On day three, the patient's status was improving with only slight weakness remaining. The patient was treated with standard dual antiplatelet treatment (dapt). The surgeon did not believe the stenosis was related to the issues with the first stent.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key10264838
MDR Text Key203100295
Report Number2029214-2020-00685
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/27/2021
Device Model NumberPED-450-10
Device Catalogue NumberPED2-450-10
Device Lot NumberA999435
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/28/2018
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: 07/13/2020 Patient Sequence Number: 1
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