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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Pain (1994); Perforation of Vessels (2135)

Event Date 09/21/2022

Event Type  Death  

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a severely calcified lesion of the proximal left anterior descending artery (lad).Intravascular ultrasound revealed more than 180 degrees of calcium arc in a 4-4.5mm vessel.Three treatments were performed successfully on low speed for less than twenty-five seconds.One additional treatment was performed on high speed.The patient immediately experienced back pain and chest pain.Angiogram imaging was performed and revealed a perforation of the lad proximal to the area of treatment.The patient then experienced pulseless ventricular fibrillation and ventricular tachycardia and advanced cardiac life support (acls) measures were performed.A temporary pacemaker was placed to treat arrhythmia.Stent placement, balloon tamponade, and pericardiocentesis were performed to treat the perforation.Approximately 500mls of blood was aspirated.The patient was pronounced deceased after over thirty minutes of acls measures.

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.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.Csi id: (b)(4).

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15641786
• MDR Text Key: 302113979
• Report Number: 3004742232-2022-00247
• Device Sequence Number: 1
• Product Code: MCX
• 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: 10/20/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White