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 Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

The oad was returned to csi for analysis.There were no abnormalities or damage observed on the oad that could have contributed to the event.When tested, the oad functioned as intended.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: 12513.

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a calcified lesion in the proximal left anterior descending artery (lad).The patient's creatine level was high, and the physician did not want to introduce unnecessary dye.The patient's ejection fraction (ef) was around 20%.When the viperwire advance guide wire was introduced into the patient, hypotension occurred prior to insertion of the oad, and neo-synephrine was administered.Two low speed treatments were performed proximal to distal.No additional treatment was performed due to the hypotension and new st elevation.The oad was removed, and a crystalized material was observed on the driveshaft.A scoreflex balloon was used to modify the lesion and the results of the inflation were good.Angiographic imaging showed no distal flow in the lad and in the distal circumflex artery (cfx).Balloon angioplasty was performed on the distal lad, and flow improved, though it worsened again after a short period of time.Balloon angioplasty was performed on the cfx, with no improvement.Integrilin was injected into the cfx, and the patient went into ventricular fibrillation.The patient coded, and cardioversion was applied twice.Cardiopulmonary resuscitation (cpr) was administered, and the patient recovered.Angiographic imaging was performed again, and thrombus was identified in the distal lad and distal cfx.The patient went into ventricular fibrillation again and was treated until recovered.The physician decided to discontinue the procedure.The patient was kept on intravenous (iv) integrilin and amiodarone overnight.The next day, the patient was stable and alert.The patient was discharged on a life vest.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16218981
• MDR Text Key: 307879663
• Report Number: 3004742232-2023-00012
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240731(10)442668-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2023

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 Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 442668-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White