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 Problem Myocardial Infarction (1969)

Event Date 12/10/2013

Event Type  Injury  

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in 3mm, 90% stenosed, heavily calcified proximal left anterior descending artery (lad).The oad was spun for 4 treatments on low speed for thirty seconds.Angioplasty and a stent were placed using non-csi/abbott devices.The patient had elevated troponin the morning post procedure.Medications of aspirin, blood thinner and beta blocker were administered.There were no complaints of chest pain or shortness of breath.The patient was discharged with no further complications.The clinical event committee review concluded the use of the diamondback 360 coronary orbital atherectomy device (oad) may have caused or contributed to the myocardial infarction type 4a in the mid left anterior descending artery (lad).

Manufacturer Narrative

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

• 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: 19212445
• MDR Text Key: 341383394
• Report Number: 3004742232-2024-00172
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)210930(10)289075
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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 Expiration Date: 09/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 289075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White