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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional 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 material inspection report for this guide wire 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 prior to distribution.The oad used during the procedure was returned and analysed, and functioned as intended with no anomalies noted.The diamondback coronary orbital atherectomy system instructions for use manual states that slow flow is a potential adverse event that may occur and/or require intervention.(b)(4).
Event or Problem Description
The coronary viperwire guide wire was used to cross two 95% stenosed lesions in the mid left anterior descending artery (lad), following which slow flow was noted.The diamondback coronary orbital atherectomy device (oad) was then inserted and operated briefly, however the patient destabilized before the device could cross the lesion and the device was removed.Pharmacological intervention was performed to address the severe hemodynamic changes and an attempt was made to cross the lesion with a balloon, however this was not possible due to a lack of wire support.Cardiopulmonary resuscitation and defibrillation were performed per hospital protocol and a ventricular assist device was successfully deployed.A temporary pacemaker was inserted, the lesions were crossed with a non-csi wire and cascading balloon inflations were performed successfully.Multiple stents were placed across the lesions and revascularization was achieved.The patient was severely compromised after the procedure due to the severe infarct caused by the abrupt vessel closure.The patient was transferred to intensive care and expired the same day.Per the opinion of the physician, the viperwire guide wire contributed to the slow flow observed after lesion wiring.However, the abrupt closure and patient death were not caused by csi devices.The patient issues were due to the anatomy and severity of the lesions and the same outcome would have resulted from any coronary intervention.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 9356146
• Report Number: 3004742232-2019-00300
• Device Sequence Number: 13570527
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)191130(10)10942437
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 10942437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 53