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 Death (1802); Low Blood Pressure/ Hypotension (1914); Left Ventricular Failure (1948); Respiratory Distress (2045); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 09/30/2019

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.(b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used to treat a type c, 80% stenosed, heavily calcified lesion in the proximal to mid left descending coronary artery (lad).The vessel diameter was 3.0mm, and the vessel was mildly tortuous.The patient also had a completely occluded lesion in the right coronary artery (rca), which was being fed by left and right collaterals.After several treatment passes with the oad for the lesion in the lad, slow flow developed and the patient's blood pressure was dropping.The physician decided to stop treatment with the oad and continue the procedure with ballooning and stenting.Medications were delivered to help with the patient's blood pressure and the slow flow.Two of the tight proximal lesions were not dilatable.When high pressure inflations were attempted with the balloons, dissections occurred.Subsequently, the patient began to have difficulty breathing and their blood pressure continued to drop.No effusion was observed on an echo, but the patient's left ventricle function was worsening.Iabp placement was performed and the patient's blood pressure initially stabilized, however, the patient's respiratory status declined, and the patient was intubated.Imaging was performed, and normal, timi 3 flow had been restored to the lad.The patient expired the day following the procedure.The physician described the cause of death as worsening left ventricle function and respiratory failure that eventually led to death.The opinion of the physician was that orbital atherectomy contributed to the decline of the patient through the initial slow flow.

• 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: 9166214
• MDR Text Key: 161532915
• Report Number: 3004742232-2019-00262
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210331(10)265270
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 10/08/2019

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: 03/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 265270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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; Required Intervention
• Patient Age: 70 YR