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	08/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The filter was received at csi for analysis and was initially unable to be retrieved into the returned retrieval catheter during testing.There was biological material accumulation observed on the proximal filter frame section.After removal of the biological material, the filter was able to be partially retrieved.There is also material in the filter sac that had become dried and hardened in the time after the procedure, which prevented the filter from being fully retrieved during analysis.It is hypothesized that the biological material accumulation on the proximal filter frame contributed to the retrieval issues, however this was not confirmed.Analysis of the device did not identify any damage that may have contributed to the accumulating material.The morphology and exact root cause of the accumulated biological material is unknown.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).Csi id: (b)(4).
Event or Problem Description
The wirion filter would not retract into the retrieval catheter.Two additional non-csi catheters were inserted to retrieve the filter but were unsuccessful.The 6fr sheath was exchanged to an 8fr sheath with the viperwire guide wire externalized, and an additional non-csi guide wire was inserted through the sheath.Leaving the wire in place, the sheath was retracted while manual pressure was held on the femoral artery, allowing the viperwire and filter to be removed.Angiography was performed and the vessel was patent.The patient remained stable throughout the procedure.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination revealed driveshaft filars were fractured at the tip bushing and confirmed that the tip bushing was missing.Scanning electron microscopy analysis of the fractured filar faces showed evidence of possible fatigue striations, however this was not conclusively determined due to the surrounding laser weld recrystallization region.It was determined that the fractured occurred within the weld due to evidence of the partial weld width remaining on the driveshaft filars, and the amount determined to have remained attached to the tip bushing after the fracture occurred.There were no manufacturing issues with the laser weld.Review of the device data log identified a stall event after the fifth spin.At the conclusion of the device analysis investigation, the report that the device was stuck in the vessel could not be confirmed through analysis.The report that the device had fractured was confirmed.It is possible that the reported unsuccessful attempt to cross the lesion followed by a stall may have applied enough stress to surpass the design limits of the weld, although this could not be confirmed and the root cause of the fractured driveshaft remains undetermined.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).

• 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: 12475819
• Report Number: 3004742232-2021-00320
• Device Sequence Number: 3744737
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230521(10)0000094895
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/29/2021

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: 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: 08/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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
• Patient Age: 79 YR
• Patient Weight: 104