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

Model Number	WRN-D6
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
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
During a critical limb ischemia procedure, previously placed kissing stents created a tight bifurcation.A balloon was used to pretreat tight lesions in the superficial femoral artery (sfa) and ostial sfa.The wirion embolic protection device was prepared and advanced into the body.Due to the anatomy of the lesion, the filter was unable to advance past the distal lesion, and was removed undeployed.Orbital atherectomy was performed through the entire vessel on low speed.A new filter was opened and was still difficult to deploy past the lesion.The filter was eventually able to advance past the lesion.The vessel was treated again with orbital atherectomy and balloon angioplasty with a good result.Upon removal attempts, the filter was unable to be reached with the retrieval catheter.A non-csi catheter was inserted and all devices were removed together with no patient complications.Particulate was observed in the filter.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h1, h2, h3, h6, h10.The wirion eps retrieval catheter was returned to csi for analysis.The filter was not returned.Analysis of the catheter revealed a separation in the shaft.It is unknown if the reported issues advancing through the anatomy led to the damage seen on the catheter, or if the damage on the catheter contributed to the difficulty experienced during the procedure.It is possible that the damage is related to the reported event, however this could not be confirmed.As the filter was not returned for analysis, it could not be determined if it contributed to the reported event.The material inspection report for this device 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.(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: 12436484
• Report Number: 3004742232-2021-00315
• Device Sequence Number: 3580728
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230411(10)0000087909
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/16/2021

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: 04/11/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000087909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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