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

Model Number GWC-12325LG-FT

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

Patient Problems Vasoconstriction (2126); Discomfort (2330); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/18/2023

Event Type  Injury  

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a tortuous mid left anterior descending artery (lad).After three treatments, angiographic imaging revealed abrupt closure of the lad.The patient experienced chest discomfort.A stent was placed, which restored timi i flow into the stent portion of the vessel, but there was still timi 0 flow in the lad.A buddy wire was run beside the viperwire advance guide wire to advance a second stent.This restored timi-3 flow down the lad.When the viperwire was attempted to be withdrawn, it entrapped beneath the second stent.A non-csi catheter was advanced over the viperwire and constant pressure was applied while retracing.The viperwire fractured, and the spring tip entrapped in the first placed stent.The first placed stent had collapsed most of the lumen, as the wire was retracted, and the stent foreshortened.The patient was taken to cardiothoracic surgery.

Manufacturer Narrative

E4: uf/importer report number: (b)(4).H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that abrupt vessel closure is a potential adverse event that may occur and/or require intervention with use of the system.H6 health effect - clinical code 4581: slow/no flow.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 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17976460
• MDR Text Key: 326178879
• Report Number: 3004742232-2023-00260
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)241031(10)458264-1
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2023

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 458264-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White