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

Model Number DBEC-125

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Respiratory Arrest (4461); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2021

Event Type  Death  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used to treat a 99% stenosed lesion in the moderately tortuous left anterior descending artery (lad) in a proximal to distal direction.During treatment, the oad became stuck and no flow occurred.An attempt was made to spin the oad while it was stuck in the vessel, and the driveshaft was observed to fracture.A ventricular assist device was inserted.The oad was unable to be removed manually, and a.75 mm balloon was used proximally to the lesion in an attempt to remove the oad.This attempt was unsuccessful, and a 2 mm balloon was inflated next to the oad driveshaft which enabled all oad components to be removed.Following use of the 2 mm balloon, a perforation occurred at the site in which the balloons were placed.Percutaneous cardiopulmonary support was performed and the patient was transferred to surgery, however the patient entered cardiopulmonary arrest and expired before the surgery could be performed.Per the opinion of the physician, the primary cause of death was cardiopulmonary arrest, and the oad contributed to the perforation.

Manufacturer Narrative

The oad was returned with the guide wire engaged.The driveshaft was observed to be fractured at the distal edge of the crown and the distal fractured section was located near the spring tip.Driveshaft flexing at the weld location can initiate a fatigue failure, and scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.At the conclusion of the device analysis investigation the reported driveshaft fracture was confirmed.The exact root cause of the fracture is undetermined.The reported patient adverse events could not be confirmed through analysis.It should be noted that the coronary oas ifu states the following warning, "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." one device of this lot was discarded prior to distribution due to a crown weld issue.Based on this analysis it is unknown if this was related to this event.(b)(4).

• 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; st. paul, mn MN 55112
• MDR Report Key: 11563057
• MDR Text Key: 242040899
• Report Number: 3004742232-2021-00090
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005794
• UDI-Public: (01)10852528005794(17)220930(10)344342
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

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: 09/30/2022
• Device Model Number: DBEC-125
• Device Lot Number: 344342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 51