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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 PED2-475-14
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem Vasoconstriction (2126)
Event Date 11/10/2020
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 pipeline initially was opened in the m1, and the physician planned to bring the stent back to the landing zone proximal to the posterior communicating (pcom) artery. The distal segment of the braid opened well, and the stent was drawn back to the internal carotid artery landing zone. There was difficulty opening around the clinoid bend which required resheathing several times and the system eventually unloaded to centralized. The doctor needed to wag the microcatheter to encourage the braid to open eventually with slight forward pressure. The middle section opened nicely and looked well opened to the vessel wall. The last proximal section appeared to be slightly stretched and not opening well. Resheathing was performed many times, and the catheter was wagged, the system as unloaded, but it still did not open. At this point, the patient's blood pressure was rising, and a column of contrast sat at the petrous segment with slow flow. The whole system was removed at this point, and vasospasm was noted. The physician suspected dissection, but it was confirmed via imaging there was no dissection. The vasospasm resolved on its own after 10-15 minutes. A smaller device was then used with new catheters. The new products were delivered easily and the pipeline opened with no issues. There was good result with the patient post-procedure. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysms of the left ophthalmic artery with a max diameter of 4 mm and a 2. 5 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered via prasugrel and aspirin.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10840757
MDR Text Key216375965
Report Number2029214-2020-01129
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 02/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-14
Device Catalogue NumberPED2-475-14
Device Lot NumberA745315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2018
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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