MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; 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); Heart Block (4444); Restenosis (4576)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that restenosis of vessels is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a lesion in the mid left anterior descending (lad) artery on (b)(6) 2019.Two drug-eluting stents were placed.During a two-year follow up in clinic on (b)(6) 2021, the patient experienced chest tightness and was provided information regarding cardiac rehabilitation.Electrocardiogram (ekg) revealed normal sinus rhythm (nsr) and left anterior fascicular block (lafb), unchanged.Patient called site on (b)(6) 2022 indicating chest tightness for the past four to six weeks and tingling down his right arm.He was advised to go to emergency room but requested an appointment.He was seen in clinic on (b)(6) 2022.Ekg that day revealed nsr, possible left anterior (la) enlargement, incomplete right bundle branch block (rbbb), and left anterior fascicular block (lafb).Due to high risk for coronary artery disease (cad), he was scheduled for left heart catheterization (lhc).Percutaneous coronary intervention (pci) on (b)(6) 2022 revealed in-stent restenosis (isr) of lad and right coronary artery (rca).The mid lad was stented, and he was scheduled for staged procedure to address the rca.During pci on (b)(6) 2022 the proximal rca was stented.The physician was unable to conclude that the oad did not contribute to the event.The patient was stable.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• 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: 18530306
• Report Number: 3004742232-2024-00089
• Device Sequence Number: 12705843
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: 01108525280054281720103110244575
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2024

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: 10/31/2020
• Device Model Number: DBEC-125
• Device Lot Number: 244575
• 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: Not provided
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American