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

Model Number PRD-SC30-MICRO

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The oad was returned with the driveshaft severely stretched and cut 32cm from the tip.A 335cm long section of the guide wire was engaged in the stretched oad driveshaft section.Biological material was observed to have accumulated on the driveshaft on the proximal edge of the crown.A second section of guide wire measuring 184cm long and cut at the distal end was returned unattached to the oad.Complaint details indicate the driveshaft was cut as part of troubleshooting and removal efforts of the oad during the procedure.The material accumulation and stretched filars on the proximal side of the crown are consistent with the crown becoming seized in biological material and the driveshaft being pulled with force in removal attempts resulting in the driveshaft damage.Damage that could have contributed to the material accumulation was not identified.The morphology and exact root cause of the accumulated biological material is unknown.When tested the oad functioned as designed.Review of the device data log identified two stall events.It is unknown if the stall events are related to the reported complaint.The exact cause of the oad getting stuck in the vessel 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.Results code: 4247 - suggested code is biological material present on device.Csi id: (b)(4).

Event Description

The stealth 360 gen 2 peripheral orbital atherectomy device (oad) was advanced without issues through the peroneal artery via femoral retrograde approach but got stuck distally.The target lesion in the peroneal was calcified, 99% diffuse, and approximately 150mm in length.The oad was cut at the driveshaft where it meets the crown to facilitate its removal.The oad and crown were successfully removed separately.In the opinion of the physician the oad was advanced too far beyond the lesion and went in to too small of a vessel.Following atherectomy, balloon angioplasty was performed.The patient was stable.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18499014
• MDR Text Key: 332727272
• Report Number: 3004742232-2024-00075
• Device Sequence Number: 1
• Product Code: MCW
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRD-SC30-MICRO
• Device Lot Number: 485070-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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