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); Death (1802); Perforation of Vessels (2135); Cardiogenic Shock (2262)

Event Date 04/29/2020

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.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.Csi id# (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used in a procedure to treat a 90% stenosed, intermediately calcified lesion in the proximal left anterior descending coronary artery (lad) via a femoral approach.The vessel was 3.5 mm in diameter with very mild tortuosity.Two treatment passes were performed on low speed, and the device was then switched to high speed.During the first treatment pass on high speed, the patient experienced chest pain.Treatment was stopped, and imaging identified a perforation in the lad, proximal to the lesion.It was noted that the treatment had been started just proximal to the lesion.The device was removed, and a covered stent was placed at the site of the perforation.A small-to-medium sized effusion was observed, however, no additional treatment was performed as the patient was asymptomatic.The patient was transferred to the intensive care unit in stable condition after the procedure for overnight observation.The patient was brought back to the cath lab overnight due to chest pain, and pericardiocentesis was performed.The patient passed away on (b)(6) 2020.The primary cause of death was reported to be the perforation to the lad that lead to 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10057504
• MDR Text Key: 190983487
• Report Number: 3004742232-2020-00139
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)210930(10)290174
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 290174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 81 YR