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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. WIRION EMBOLIC PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

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CARDIOVASCULAR SYSTEMS, INC. WIRION EMBOLIC PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number WRN-D6
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
The wirion filter and retrieval catheter were received at csi for analysis.A visual examination of the retrieval catheter revealed that the filter frame was fractured, and the filter sac was detached at the fractured site.Scanning electron microscopy analysis showed ductile dimples and possible evidence of fatigue.At the conclusion of the device analysis investigation, the report that the part of the filter basket was exposed off of the filter was confirmed.It was hypothesized that the filter and frame became damaged due to manipulate during the procedure, where the filter likely was exposed to unknown stresses.This is consistent with the details reported to csi which state that "the filter was continuously advanced and retracted to its intended location." however, this was not confirmed, and the cause of the fracture remains unknown.The material inspection report for this wirion filter lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).
 
Event Description
The wirion filter was deployed into the distal popliteal and multiple exchanges were made over the wire.The filter was continuously advanced and retracted to it's intended location.During removal, it was revealed that part of the filter basket was exposed.There were no patient adverse events.Device analysis identified that the returned filter frame was fractured.
 
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Brand Name
WIRION EMBOLIC PROTECTION SYSTEM
Type of Device
EMBOLIC PROTECTION DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key12758906
MDR Text Key281745118
Report Number3004742232-2021-00361
Device Sequence Number1
Product Code NTE
UDI-Device Identifier10850000491882
UDI-Public(01)10850000491882(17)230210(10)0000077278
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/10/2023
Device Model NumberWRN-D6
Device Catalogue Number7-10078-01
Device Lot Number0000077278
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient RaceWhite
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