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

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

Patient Problems Bradycardia (1751); Chest Pain (1776); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 01/01/2023

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 could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used for one antegrade treatment and one retrograde treatment.The patient experienced chest pain post-atherectomy.Angiographic imaging showed an aortocoronary dissection.During an attempt to exchange wires, the viperwire advance guide wire access was lost.While re-wiring, the patient developed bradycardia.A temporary pacemaker was placed.Echocardiographic imaging revealed a pericardial effusion.Pericardiocentesis was performed and 25 cubic centimeters of fluid was removed.The patient became stable.The physician was able to successfully re-wire.Stent placement was attempted, however, the dissection persisted with contrast extravasation.An additional stent and sapphire balloon were used to treat the dissection.The patient was admitted to the intensive care unit.The patient became dyspneic, and x-ray imaging showed pleural effusion.Pleural puncture was performed.The patient remained dyspneic.The non-contrast computed tomography (ct) scan showed hemopneumothorax.Hemorrhagic fluid was drained.The patient was stabilized and discharged with medication administered.Hardi et al.2023 "managing (almost) every procedural complication imaginable - a case of right coronary artery orbital atherectomy".

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ORBITAL ATHERECTOMY SYSTEM
• 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: sadie martin ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16977601
• MDR Text Key: 315747460
• Report Number: 3004742232-2023-00137
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 45 KG