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 Myocardial Infarction (1969); Ischemic Heart Disease (2493); Vascular Dissection (3160)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection and myocardial infarction are potential adverse events that may occur and/or require intervention with use of the system.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).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used for atherectomy treatment of 27 patients.The lesions treated were 5 left main arteries, 21 left anterior descending arteries, 1 left circumflex artery, and 5 right coronary arteries.All 27 patients experienced myocardial injury.Myocardial injury was defined as elevated hstroponin 1 above the 99th percentile upper reference limit.Myocardial infarction occurred in 2 patients, who experienced severe coronary dissections post orbital atherectomy.Ledwoch, j., styllou, p., klauss, v., leibig, m., luciani, e., koutsouraki, i., freymüller, c., & leber, a.(2024).Myocardial injury after orbital atherectomy and its association with coronary lesion length.Cardiovascular revascularization medicine.Https://doi.Org/10.1016/j.Carrev.2024.03.022.

• 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: 19154963
• MDR Text Key: 340801296
• Report Number: 3004742232-2024-00176
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 83 KG