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

Model Number PRD-SC30-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Additional information: the physician attributed the dissection to the patient's disease state and anatomy, but it is unclear whether the oad contributed to the dissection.Device analysis conclusion: the oad was returned to csi for analysis.Visual examination did not reveal any damage that would have contributed to the reported dissection.The oad operated as intended during functional testing.The device data was downloaded and analyzed.The data did not reveal any stall condition during the procedure.As the guide wire was not returned, it could not be determined if it had contributed to the reported complaint.At the conclusion of the device analysis investigation, the reported stall could not be confirmed.The root cause of the dissection also 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.Csi id: (b)(4).

Event Description

A stealth pluto orbital atherectomy device (oad) was selected for treatment of a heavily calcified common femoral stenosis with ostial superficial femoral artery chronic total occlusion via left common femoral antegrade access.Following several treatments in the proximal lesion and one distal treatment, the oad stalled.When tested ex vivo, the device operated as intended.During the second attempt at distal treatment, the issue recurred.A dissection was noted on angiogram after the oad was removed from the patient and after angiography had been performed.The dissection flap occluded the vessel.A stent was placed, and the dissection was resolved.The procedure concluded with angioplasty and stent placement with no further indication of dissection or perforation.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ORBITAL ATHERECTOMY 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: 10502605
• MDR Text Key: 205998365
• Report Number: 3004742232-2020-00272
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)220331(10)316502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 316502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 78