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 ST Segment Elevation (2059); Vascular System (Circulation), Impaired (2572)

Event Date 09/20/2019

Event Type  Injury  

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.Patient age is approximate, they are in their mid-70's.(b)(4).

Event Description

During use of a coronary diamondback orbital atherectomy device (oad) the patient experienced slow flow and exhibited st elevation.The oad was operated for two treatments on low speed with no issues observed.At this time there was slow flow and st elevation noted, which were improved with nitroglycerin and plain old balloon angioplasty (poba), but did not resolve.The procedure was completed with bifurcated stent placement.The patient left the procedure with timi grade 3 flow and no dissections noted, however the st elevation continued and the patient presented with chest pain.The patient was returned from the holding area with continued chest pain.An electrocardiogram was performed, and revealed acute stent thrombosis which was resolved with poba.An impella device was implanted and the patient exhibited excellent hemodynamics.The patient later had elevated lactate levels resulting from the site where the impella device was placed, and antegrade access relieved the lactic acidosis, but resulted in reperfusion edema in the limb.The patient was transferred to an outside institution for additional treatment, and eventually was placed on extracorporeal membrane oxygenation.The patient could not recover and the family removed all life saving measures.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 9321986
• MDR Text Key: 166372369
• Report Number: 3004742232-2019-00294
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210131(10)254417
• 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: 11/14/2019

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: 01/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 254417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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): Required Intervention
• Patient Age: 75 YR