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

Model Number	WRN-D6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
The retrieval catheter of the wirion embolic protection system would not capture the filter due to the filter being full.A catheter was inserted in an attempt to retrieve the filter, and when the physician pulled hard the tip of the filter became detached.A stent was placed over the filter fragment and it remained in the patient.At the end of the procedure, imaging was performed and there was good flow.The patient was in stable condition.
Additional Manufacturer Narrative
The filter and retrieval catheter were received at csi for analysis.The filter sac was observed to be torn, and the distal section of the filter was not returned.The filter frame exhibited two fractures.There was no other damage observed with the filter frame or the retrieval catheter.Scanning electron microscopy analysis showed evidence of possible fatigue, however this was inconclusive and the cause of the fracture remains unknown.It is hypothesized that the filter became torn and the frame fractured during the manipulation and retrieval attempts of the filter, however this was not confirmed and the root cause is undetermined.The material inspection report for this 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).

• 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
• MDR Report Key: 12384403
• Report Number: 3004742232-2021-00310
• Device Sequence Number: 4634235
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230404(10)0000086622
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 04/04/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000086622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 113