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	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The filter system was received at csi for analysis.The detached section of the filter was determined to be due to a torn filter sac.The filter frame was able to collapse and be retrieved into the retrieval catheter and back out of the catheter without issue.The exact cause of the detachment is unknown.It is possible that the filter sac was full beyond the capabilities of the retrieval catheter and the filter sac was unable to compress to fit within the retrieval catheter.This could have led to the retrieval catheter tip applying force against the filter sac.At the conclusion of the device analysis investigation, the reported event was confirmed, however the root cause could not be conclusively determined.The device history record 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).
Event or Problem Description
The wirion filter was deployed per the ifu with no issues noted.Atherectomy and balloon angioplasty were performed and it was noted that the balloon was difficult to remove over the wire.A guide wire control device was used during the procedure.The filter retrieval device was inserted and an attempt to retrieve the filter was made.The filter was captured and resistance was felt when attempting to remove the wire and filter together.The physician pulled back, and the resistance abruptly released.The filter separated into two halves and was visualized via fluoroscopy.The retrieval catheter, guide wire and upper portion of the filter were removed from the patient.The lower portion of the filter was located at the origin of the posterior tibial artery and a micro snare was used to successfully remove it from the patient.The final angiogram showed no vessel issues at the completion of the procedure.

• 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: 11626977
• Report Number: 3004742232-2021-00114
• Device Sequence Number: 3547057
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)221227(10)0000068706
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/07/2021

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: 12/27/2022
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000068706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/07/2021
• 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