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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation conclusion: the filter was returned to csi for analysis engaged on the guide wire.The filter was not retrieved within the catheter.The filter sac is torn at the distal end.The distal section was returned, which confirms the report that the filter detached.The filter frame was able to be pulled into the retrieval catheter without issue during testing.The filter frame did not exhibit any fractures.The distal filter sac and tip section did not reveal any damage that would have contributed to the separation.It is possible that the filter was not fully captured in the retrieval catheter during removal, thereby resulting in the filter separation.This is consistent with details reported to csi.This hypothesis could not be confirmed, and the root cause of the filter separation remains unknown.The material inspection report 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.(b)(4).
Event or Problem Description
The wirion filter was deployed successfully in the distal popliteal over a viperwire guide wire.Atherectomy and angioplasty were performed successfully in distal superficial femoral artery and proximal popliteal artery.The filter was retrieved successfully after intervention.Upon retracting the retrieval catheter, the doctor felt some resistance within the sheath just prior to the device exiting.He manipulated the retrieval catheter forward and rotated it.He was able to remove it from the sheath, but the distal end of the filter remained within the sheath just at the proximal access point just past the valve.The physician successfully removed the sheath, which contained the distal end of the filter.He believes part of the filter became exposed while coming out of the sheath/valve and got stuck.There were no patient complications.

• 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: 12636612
• Report Number: 3004742232-2021-00345
• Device Sequence Number: 19928434
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230223(10)0000079994
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000079994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1