MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK CORONARY; CORONARY ATHERECTOMY DEVICE

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969); Restenosis (4576)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that angina, myocardial infarction, slow/no flow to vessel, and restenosis of treated segment leading to revascularization are potential adverse events that may occur and/or require intervention with use of the system.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.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 or Problem Description
The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment of an 80% stenosed, severely calcified lesion in mid right coronary artery (rca) via right femoral on (b)(6) 2022.Six low-speed treatments were performed.The procedure was completed with balloon angioplasty and stent placement.During a follow-up visit in clinic on (b)(6) 2023, the patient was admitted for recurrent chest discomfort and elevated troponins consistent with type one non-q-wave non-st-elevation myocardial infarction (nstemi) with acute myocardial ischemia.The mid rca lesion was found to be 90% stenosed with in-stent restenosis (isr).Balloon angioplasty and two stent placements were performed to resolve the nstemi.The patient was discharged home the following day without further complications and medical intervention.In the opinion of the physician, the csi device did not cause or contribute to the myocardial infarction and isr - nstemi was secondary to isr.On 15july2024, additional information was received from the clinical event committee (cec).The cec reviewed procedural images and concluded that the diamondback 360 peripheral orbital atherectomy device possibly contributed to a myocardial infarction with chest pain.No further information is available.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19963588
• Report Number: 3004742232-2024-00178
• Device Sequence Number: 7080493
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240331(10)427486-2
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 427486-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White