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

Model Number	WRN-D6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The filter and retrieval catheter were received at csi for analysis.The filter sac was returned torn and the distal section was not received.The filter also exhibited a frame strut fracture.During functional testing, the filter frame was unable to be fully pulled into the retrieval catheter, likely due to the fractured frame strut.It is possible that the filter was not fully captured in the retrieval catheter during removal, resulting in the filter separation, however this could not be confirmed.The root cause of the damaged filter is undetermined.Microscopic analysis of the fractured filter frame showed evidence of possible fatigue, which is an indication that the filter frame was exposed to a high stress environment.However, the exact root cause of the fracture remains undetermined.The material inspection report for this device 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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
A wirion embolic protection system filter was used during atherectomy treatment of a highly calcified lesion in the superficial femoral artery.The filter basket was not full following treatment.During retrieval of the filter, all three indicators appeared to be within the retrieval catheter, however a small amount of resistance was met and a portion of the filter basket detached while it was being pulled through the sheath.The filter fragment was stented to the vessel wall.The patient was in good condition following the procedure.Per the opinion of the physician, the filter may have become caught on the edge of the sheath during removal.

• Brand Name: WIRION EMBOLIC PROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 12954774
• Report Number: 3004742232-2021-00410
• Device Sequence Number: 14631630
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230210(10)0000077278
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American