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	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device analysis conclusion: the filter and guide wire were received at csi for analysis.The filter was returned with a torn filter sac.It is unknown why removal of the filter was difficult.The report that the user pulled the filter forcefully through the sheath likely contributed to the torn sac; however, this could not be confirmed.The root cause of the filter damage remains unknown.It should be noted that the wirion® embolic protection system instructions for use manual warns, "always advance or retract the catheter slowly under fluoroscopic imaging.If resistance is felt and/or observed, determine the cause and take any necessary remedial action." the device history record for this oad 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.Csi id: (b)(4).
Event or Problem Description
Following successful use in the distal popliteal artery, the wirion filter was captured and removed.The user had left groin access with contralateral approach; right side peripheral vascular intervention of the superficial femoral artery and proximal popliteal artery had been performed.During removal, the 6fr filter was difficult to remove through the 6fr sheath.The user pulled the filter forcefully through the sheath, and it became stuck.The components were removed together.The distal marker and a small part of filter fractured and was likely left in vivo.The procedure was completed, and the patient was discharged home in stable condition.

• Brand Name: WIRION EMBOLIC PROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 12139218
• Report Number: 3004742232-2021-00251
• Device Sequence Number: 4180417
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230216(10)0000078498
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 02/16/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000078498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/08/2021
• 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: Other