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

Model Number PRD-SC30-200

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

Patient Problems Embolism (1829); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 02/25/2019

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 the reported oad was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a procedure with a peripheral orbital atherectomy device (oad), slow flow and no reflow occurred due to embolization of the lesions.The target lesions were a 110 mm chronic total occlusion located proximal through distal in the superficial femoral artery (sfa) and popliteal artery (pop), and a 40 mm chronic total occlusion located in the distal anterior tibial artery (at).All lesions were severely calcified.During the procedure, there were complications with the lesions including embolization, slow flow, and no flow.The physician's opinion was the embolization was a result of orbital atherectomy and no distal outflow.The lesions were stented, and the procedure was halted.The patient lost color and pulse in the foot, and the patient was admitted for monitoring as amputation was considered.Color and pulse returned to the foot, and the patient was discharged home.The oad reported to have performed as expected.

Event Description

It was reported on (b)(6) 2019 that the patient still had a pulse signal in their foot and peroneal artery, but they had bilateral wounds on their feet and a below-the-knee amputation was planned.The oad reported to have performed as expected and had a large orbit in the sfa during the initial procedure.On (b)(6) 2019, it was reported that the below-the-knee amputation had occurred successfully.

Manufacturer Narrative

Adverse event problem: patient code: amputation.Csi id# (b)(4).

• 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
• MDR Report Key: 8440421
• MDR Text Key: 139462858
• Report Number: 3004742232-2019-00077
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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 Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 86 YR