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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 PED3-027-450-16
Device Problem Activation Failure (3270)
Patient Problem Obstruction/Occlusion (2422)
Event Date 04/21/2021
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 proximal segment of the pipeline vantage failed to open. The patient was undergoing treatment for a ruptured blister aneurysm located in the distal right ica between the posterior communicating and anterior choroidal arteries. The max diameter was 2. 5mm, and the neck diameter was 2mm. The patient's vessel tortuosity was normal.  dual antiplatelet treatment was administered; iv 500mg administered before the stent was deployed. No second agent pre-deployment as it was a ruptured case. It was reported that the pipeline was deployed across the aneurysm neck. The proximal end of the flow diverting stent was moderately narrowed due to the extrinsic compression at focal arterial tortuosity and stenosis at the level of the right ophthalmic artery. There was difficult access through the lumen of the stent, requiring multiple wire and catheter attempts and balloon angioplasty. Following balloon angioplasty the pipeline was implanted in the patient and full wall apposition was achieved. More than 50% of the pipeline had been deployed when it failed to open. There was moderated localized platelets aggregation and transient proximal stent occlusion.  intra-procedural transient proximal stent occlusion requiring intra-arterial abciximab and iv heparin therapy despite the subarachnoid hemorrhage (sah). There was mild, non-flowing limiting proximal stent stenosis due to irregular artery morphology and despite repeated stent manipulation and stent angioplasty.  final angiogram demonstrated early flow diversion effect with patent vessels distal to the stent, and no thromboembolism complications and no dissection.  the patient did not experience any injury or symptoms. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a benchmark 071 guide catheter, phenom 27 microcatheter, synchro guidewire, and transform 4 x 20 occlusion balloon catheter.
 
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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 Key12200505
MDR Text Key263441594
Report Number2029214-2021-00890
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,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-16
Device Catalogue NumberPED3-027-450-16
Device Lot NumberB163271
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 Received08/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2021
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: 07/20/2021 Patient Sequence Number: 1
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