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

Model Number	WRN-D6
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device analysis conclusion: the device was returned for analysis.The filter sac was torn at the distal end.The distal torn section was not returned for analysis.The filter frame was able to be pulled into the retrieval catheter without issue during functional testing.It is possible that the filter was not fully captured in the retrieval catheter during removal, thereby resulting in the filter separation.However, this could not be confirmed.The root cause of the damaged filter remains undetermined.Csi id: (b)(4).
Event or Problem Description
The wirion filter was advanced into the superficial femoral artery (sfa).The vessel had multiple lesions, and the filter could not be advanced across the distal lesion.The lesion was predilated with 3mm balloon, but the filter still would not cross the lesion.The filter was deployed farther proximal than desired.The proximal lesion was treated with atherectomy without issue; the atherectomy device did not come into contact with the filter.Upon retrieval of the filter, the basket sheared or broke off.The physician suspected the torn portion was removed during retrieval since no components were seen on imaging in vivo, and there were no components externalized from the retrieval catheter.A non-csi filter was used to continue the procedure.The reason for the initial filter damage could not be determined by the physician or csi field staff.
Additional Manufacturer Narrative
Device analysis conclusion: the device was returned for analysis.The filter sac was torn at the distal end.The distal torn section was not returned for analysis.The filter frame was able to be pulled into the retrieval catheter without issue during functional testing.It is possible that the filter was not fully captured in the retrieval catheter during removal, thereby resulting in the filter separation.However, this could not be confirmed.The root cause of the damaged filter remains undetermined.(b)(4).
Event or Problem Description
The wirion filter was advanced into the superficial femoral artery (sfa).The vessel had multiple lesions, and the filter could not be advanced across the distal lesion.The lesion was predilated with 3mm balloon, but the filter still would not cross the lesion.The filter was deployed farther proximal than desired.The proximal lesion was treated with atherectomy without issue; the atherectomy device did not come into contact with the filter.Upon retrieval of the filter, the basket sheared or broke off.The physician suspected the torn portion was removed during retrieval since no components were seen on imaging in vivo, and there were no components externalized from the retrieval catheter.A non-csi filter was used to continue the procedure.The reason for the initial filter damage could not be determined by the physician or csi field staff.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12851873
• Report Number: 3004742232-2021-00391
• Device Sequence Number: 3840236
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230521(10)0000094895
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/22/2021

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 Expiration Date: 05/21/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000094895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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
• Patient Sex: Male
• Patient Race: White