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

Model Number 303654

Device Problem Material Separation (1562)

Patient Problems Vascular System (Circulation), Impaired (2572); Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

The oad and guide wire were returned to csi for analysis.The oad was fractured at the proximal edge of the crown, and the fragment was engaged on the guide wire.No additional damage was observed on the oad or guide wire.The guide wire passed through the oad with no resistance.The oad functioned as intended during testing.Scanning electron microscopy yielded inconclusive results due to polished fracture surfaces or smearing.One of the fractures showed evidence of torsion.Based on lesion details provided by the site, it is hypothesized that the driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, the exact root cause of this reported complaint is undetermined.The diamondback 360 coronary orbital atherectomy system instructions for use states, "never force the crown if any resistance is felt within the vessel as vessel perforation may occur.If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment.Use fluoroscopy to analyze the situation and to monitor the cause of the resistance." at the conclusion of the device analysis, the reported driveshaft fracture was confirmed.The reported dissection 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.The material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided.Csi id# (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for use for a lesion in the ostial circumflex, distal left main (lm) and proximal left anterior descending (lad) coronary arteries.The lesion was calcified, and the patient had moderate aortic stenosis.The circumflex artery was treated first.The lesion was pre-dilated with balloon angioplasty, and the wire was exchanged for a csi viperwire guide wire with some difficulty.Three 10-15 second treatment passes were performed with the oad.Imaging after the third pass revealed the distal driveshaft had separated from the oad and remained on the guide wire.All pieces were removed from the patient with the fragment remaining on the guide wire throughout the removal.Additional imaging was performed, and the vessel had shut down with some flow proximally, however, a type f dissection was visible in the mid-circumflex.The vessel was re-wired, and a stent was placed, which resolved the dissection and restored flow.The procedure was then completed with balloon angioplasty and stent placement in the lm and lad with a good final result.The patient was stable following the procedure.The patient's anticipated discharge was (b)(6) 2020.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10352942
• MDR Text Key: 208131141
• Report Number: 3004742232-2020-00223
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211231(10)303654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 07/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 303654
• Device Catalogue Number: 70058-13
• Device Lot Number: 303654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• 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