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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-400-12
Device Problems Positioning Failure (1158); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline vantage that had issues with positioning and opening at the proximal end. The patient was undergoing a procedure for flow diverter implantation to treat a previously coiled saccular aneurysm of the right internal carotid artery (ica) posterior communicating (pcomm) segment. The aneurysm max diameter was 5mm and the neck diameter was 5mm. Vessel tortuosity was moderate. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline vantage stent was placed at the top end of the ica terminus. The phenom microcatheter was brought past the m1 aneurysm. The pipeline was advanced and unsheathed to place the tip coil past the m1 aneurysm. The stent was brought back to the proximal end of the m1 and deployment began. The stent opened but was observed to be too distal to the terminus after 90% was deployed so the pipeline was resheathed and repositioned more proximal. This was repeated 5 times. The stent was then in a correct position and deployed. The proximal end was enclosed on itself. The surgeon attempted to push the microcatheter through the stent to open it but the stent closed more instead. Many attempts were made but the stent remained closed. Finally a non-medtronic microcatheter was used with a non-medtronic guidewire as a "buddy wire" to get into the stent and both wires together to open the proximal end of the pipeline vantage stent. The non-medtronic microcatheter was placed through the stent and exchanged with a phenom 27 microcatheter. An additional pipeline was then also implanted. It was noted that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu). There were no patient symptoms or complications associated with this event. Post-procedure angiography showed good results.
 
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Brand NamePIPELINE VANTAGE WITH 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 Key12189634
MDR Text Key262263594
Report Number2029214-2021-00877
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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 08/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-400-12
Device Catalogue NumberPED3-027-400-12
Device Lot NumberB159989
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 Received07/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/11/2021
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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