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

Model Number DBEC-125

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

Patient Problems Chest Pain (1776); Perforation of Vessels (2135); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Vascular Dissection (3160)

Event Date 03/26/2021

Event Type  Death  

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.The review showed three previous instances of devices scrapped before distribution.It is unknown if the manufacturing scrap was related to the reported event.The device noted in this report met material, assembly, and quality control requirements prior to distribution.Csi id# (b)(4).

Event Description

The diamondback gen2 coronary orbital atherectomy device (oad) was selected for treatment of a type c, severely calcified, 70-80% stenosed lesion in the proximal and mid right coronary artery (rca).The vessel was 4.0mm in diameter and not tortuous.The lesion was wired via a radial approach.Intravascular ultrasound (ivus) was attempted, however, the ivus catheter was unable to advance in the vessel.A wire exchange was performed.The oad was inserted, and the crown jumped in a proximal to distal direction during the first treatment on low speed.Imaging showed the vessel was intact.On the third treatment, the crown jumped as the oad was moving in a distal to proximal direction.Imaging showed the vessel was intact.After the fifth treatment on low speed, the patient experienced chest pain, and morphine was administered.A perforation and a dissection were observed on imaging.Cardiac tamponade was performed, and the patient experienced hemodynamic deterioration due to the tamponade.The patient was intubated, and resuscitation was performed.Pericardiocentesis, intra-aortic balloon pump insertion, stent placement, and a blood transfusion were also performed.The patient passed away on (b)(6) 2021.The cause of death was reported to be perforation, cardiac tamponade, and cardiogenic shock.

• 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; 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: 11700314
• MDR Text Key: 246465127
• Report Number: 3004742232-2021-00143
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)230131(10)365844-1
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

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: 01/31/2023
• Device Model Number: DBEC-125
• Device Lot Number: 365844-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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): Death
• Patient Age: 71 YR