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 Hemorrhage/Bleeding (1888); Shock (2072); Perforation of Vessels (2135); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/01/2023

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 the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.The diamondback 360® coronary orbital atherectomy system instructions for use manual states that vessel perforation and vascular dissection are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

A presentation reported that during a procedure that includes orbital atherectomy, 12 bleeding complications, 3 dissections, 5 perforations, 5 cardiogenic shocks, 3 heart failures occurred from january 2014 to september 2020.Orbital atherectomy for calcified ostial coronary artery disease: a single-center experience.Amer ghazzal, presenter, selin sendil, author, christian alejandro torres, md, garly saint croix, md, brad j.Martinsen, phd, prince sethi, ralph cipriano, ajay j kirtane, m.D., fscai, martin b.Leon, m.D., nirat beohar, md.(2) mount sinai miami medical center, (2) mount sinai medical center of florida, cardiovascular systems, inc., kansas university medical center - kumc, new york - presbyterian columbia university irving medical center, columbia university irving medical center, mount sinai medical center.

• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17139834
• MDR Text Key: 317295183
• Report Number: 3004742232-2023-00162
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other