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

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.

• 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 Key: 12758906
• MDR Text Key: 281745118
• Report Number: 3004742232-2021-00361
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230210(10)0000077278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210282
• Number of Events Reported: 1
• 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 Date: 02/10/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000077278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White