MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	PRD-SC30-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The stealth peripheral orbital atherectomy device (oad) was intentionally operated subintimal and seized during treatment to the posterior tibial artery.The oad was removed, and torque build up was observed in the saline sheath.Imaging revealed a tissue embolus and aspiration was performed to remove the intima piece.Treatment was continued with a second oad and when the guide wire was removed a second piece of intima was stuck on the guide wire tip as a result of the emboli traveling downstream and becoming stuck on the guide wire.
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Per the physician, this embolus outcome was not unexpected when operating subintimal.The physician used the csi device subintimally on purpose.Csi id: (b)(4).
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Per the physician, this embolus outcome was not unexpected when operating subintimal.The physician used the csi device subintimally on purpose.Csi id: (b)(4).
Event or Problem Description
The stealth peripheral orbital atherectomy device (oad) was intentionally operated subintimal and seized during treatment to the posterior tibial artery.The oad was removed, and torque build up was observed in the saline sheath.Imaging revealed a tissue embolus and aspiration was performed to remove the intima piece.Treatment was continued with a second oad and when the guide wire was removed a second piece of intima was stuck on the guide wire tip as a result of the emboli traveling downstream and becoming stuck on the guide wire.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.A visual examination revealed that the saline sheath was twisted at the distal end.The distal end also appeared to be flared, likely from contact with the driveshaft crown.Review of the device data log identified stall events which could have been due to interaction in the sub-intimal space, or from the crown contacting the distal end of the sheath, however this could not be confirmed.When tested, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that an embolism occurred could not be confirmed through analysis.The damaged sheath could have been related to the embolism event, however this could not be confirmed and the root cause of the damage was considered to be related to use not consistent with the instructions for use (ifu).The ifu warns "do not continue if the wire or device becomes sub-intimal".The stealth peripheral orbital atherectomy device ifu also warns that an embolism is a potential adverse event that may occur and/or require intervention.Csi id: (b)(4).

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 12926997
• Report Number: 3004742232-2021-00409
• Device Sequence Number: 5476098
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)230731(10)391206-1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 7-10059-03
• Device Lot Number: 391206-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic