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

Model Number DBP-200SOLID145

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

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 10/28/2020

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.Csi id# (b)(4).

Event Description

A peripheral exchangeable orbital atherectomy device (oad) was selected for treatment of the external iliac to proximal superficial femoral artery (sfa).The common femoral artery, 7mm in diameter, had a 60% stenosed, moderately calcified lesion, and the proximal sfa, 6mm in diameter, had a totally occluded, heavily calcified lesion.The lesion was treated with orbital atherectomy, and imaging did not show any issue.Post-dilation was then performed with a scoring balloon.After balloon angioplasty, a type c dissection was observed, and an unplanned stent was placed.It was unknown if the oad contributed to the dissection.Angiography showed a distal occlusion to the tibial arteries due to a thrombus.An infusion catheter was placed from the popliteal to the distal posterior tibial artery for overnight infusion of tissue plasminogen activator (tpa).In the opinion of the physician, the thrombus was a result of using orbital atherectomy through an unappreciated thrombus at the site of the occlusion.It was noted that thrombolytics had been appropriately administered prior to the procedure.The patient was hospitalized overnight for observation and was discharged on (b)(6) 2020 with a good status.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 10848510
• MDR Text Key: 216832602
• Report Number: 3004742232-2020-00366
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)220630(10)330368
• 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: 11/16/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 330368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90