MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH PERIPHERAL 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 Codes	Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad and viperwire guide wire were received at csi for analysis.There was no damage or abnormalities identified with the oad, driveshaft or guide wire that would have contributed to the reported events.During analysis the oad functioned as intended.At the conclusion of the device analysis investigation, the reported slow/no flow and embolism could not be confirmed through analysis.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 prior to distribution.(b)(4).
Event or Problem Description
A patient with critical limb ischemia presented with heavily calcified lesions in the right superficial femoral artery (sfa), popliteal, tibioperoneal trunk (tpt) and proximal peroneal.Treatment was performed with a stealth peripheral orbital atherectomy device (oad) on all speeds in the sfa, low and medium speeds in the tpt and proximal peroneal with good technique.Balloon angioplasty was performed at all treatment locations.Angiography was performed and revealed slow flow in the sfa and popliteal and no flow in the untreated mid peroneal.The peroneal was treated with balloon angioplasty, but flow was not restored.Angiography was performed in the distal peroneal and it was found to be patent.Balloon angioplasty was performed again and angiography results were consistent with embolization of the mid peroneal.A thrombectomy device was advanced and thrombolysis was performed along with thrombectomy and administration of tissue plasminogen activator.Angiography revealed improved peroneal flow, however slow flow was still noted.Balloon angioplasty was again performed and slow flow remained, however flow in the peroneal was continuous to the foot and a doppler signal to the dorsalis pedis was present.The patient remained stable and asymptomatic and the case was concluded.

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 12790572
• Report Number: 3004742232-2021-00370
• Device Sequence Number: 4005248
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)230131(10)361623-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 01/31/2023
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 7-10059-03
• Device Lot Number: 361623-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• 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: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American