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); Perforation of Vessels (2135); Irritability (2421)

Event Date 11/02/2023

Event Type  Death  

Manufacturer Narrative

The oad was returned for analysis.There was no damage or abnormalities observed with the oad that could have contributed to the event.Review of the device data log did not identify any abnormalities 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: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a multivessel disease with lesions in the left main artery (lm), left anterior descending artery (lad), and right coronary artery (rca).Low-speed proximal to distal treatments were first performed in the lad and lm.Adenosine was administered between treatments.Thereafter, several low-speed treatments distal to proximal were performed from the lad into the lm.A high-speed treatment from the lad into the lm was performed, and imaging showed decent distal flow.There was one remaining stenotic area that intravascular ultrasound (ivus) and a microcatheter were unable to cross.A low- speed treatment was performed in this area.The patient became increasingly agitated and hypotensive.Cardiopulmonary resuscitation (cpr) was performed, and the patient was intubated.A second guide catheter was inserted so the physician could advance a balloon to continue working on the lad.The first angiogram thereafter revealed a perforation.The physician continued treatment with the balloon.There was minimal flow to the distal lad.Echocardiogram indicated a small pericardial effusion and a severe hemothorax.Minimal blood was drained during attempted pericardiocentesis.Three covered stents were placed to seal the perforation.The patient began to recover after cpr and the administered medication.A norepinephrine drip was initiated, and the patient's condition began to decline.Cpr was performed again and continued for an hour before the patient expired.In the physician's opinion, the high-speed orbital atherectomy treatment caused the perforation.

• 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: 18230542
• MDR Text Key: 329276204
• Report Number: 3004742232-2023-00292
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250831(10)502283-1
• 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: 11/29/2023

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: 502283-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG