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); Pulmonary Edema (2020); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 10/31/2019

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

Event Description

During a procedure, a diamondback coronary orbital atherectomy device (oad) was used to treat a lesion in the left anterior descending coronary artery (lad).The type c, 80% stenosed, heavily calcified lesion was located in an area of the lad that was mildly tortuous and 3.0 mm in diameter and was accessed via a femoral approach.During treatment, the patient collapsed on the table and experienced hemodynamic changes.It was noted that there was no re-flow in the vessel and acute pulmonary oedema (apo) developed.The lad was stented and emergency procedures were performed.The patient was transferred to the intensive care unit with ongoing chest compressions and triple inotropic support.There was transient pea and spontaneous breathing noted, however, the patient gradually became asystolic.Subsequently, there was no spontaneous breathing and absent heart sounds, and the patient was declared dead.The cause of death was reported to be acute myocardial infarction.The opinion of the physician was that the oad contributed to the event and death as the cause of death was multifactorial.

• 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: 9449941
• MDR Text Key: 170218370
• Report Number: 3004742232-2019-00323
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210331(10)265288
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

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: 265288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/11/2019
• 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: 57 YR