MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBE-150

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

Patient Problem Embolism (1829)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 Description

The target lesion was a heavily calcified chronic total occlusion located in the iliac, which was tortuous.A sheath was placed with difficulty and the lesion was wired with a viperwire guide wire.The crown of the stealth orbital atherectomy device (oad) was positioned proximal to the lesion, and six passes on low, medium and high speeds were performed.A thirty second rest and flushing of the device were performed following each pass.An angiogram was performed following the sixth pass, showing that a large plaque burden still remained.Two additional passes were performed, and following the second pass the oad was removed.A drug coated balloon was inflated and an angiogram performed after inflation showed a good proximal lumen.A below the knee angiogram was then performed and a filling defect was observed in the tibial peroneal trunk/peroneal junction.The filling defect was not present on the initial angiogram, and was determined to be distal embolization due to particulate.A covered stent was then placed to treat a distal area of plaque, and a thrombectomy device was used to remove the particulate.Post procedure flow to the foot was good, and the case was considered successful with no patient complications noted.Per the opinion of the treating physician, all csi devices performed as intended and this was a lesion specific incident.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: 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: 8901505
• MDR Text Key: 154559556
• Report Number: 3004742232-2019-00215
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491073
• UDI-Public: (01)10850000491073(17)211231(10)250321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: DBE-150
• Device Lot Number: 250321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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