MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. 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	Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	07/12/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that myocardial infarction and thrombus are potential adverse events 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).
Event or Problem Description
Access was gained through the right femoral artery.A 6fr sheath was used to advance the diamondback 360 coronary orbital atherectomy device (oad) to the ramus artery.The vessel was 2.75mm, 90% stenosed, 15 mm in length, heavily calcified, with 15mm total length of calcium.The oad was spun for treatment five times on low speed.Angiographic imaging was performed post oad.Angioplasty and stent placement were performed to complete the procedure.The patient was admitted to the hospital on (b)(6) 2019 for nstemi, medication of troponin was administered.Cardiac catheterization on (b)(6) 2019 revealed in-stent thrombosis of ramus intermedius.Medication of heparin and integrillin drip, along with albuterol with aspirin were administered to treat the thrombus.The patient became severely anemic and required two blood transfusions.Due to the patient's comorbidities, anemia, and high-risk percutaneous coronary intervention (pci), it was decided to not proceed with aggressive treatment.Patient was discharged to home hospice on (b)(6) 2019.The patient was admitted to the hospital on (b)(6) 2020 for hypertensive heart disease with heart failure and expired on (b)(6) 2020.The site was alerted by fax of the patient passing on (b)(6) /2020.Per the principal investigator (pi), the cause of death was ischemic dilated cardiomyopathy with low ejection fraction (ef).The clinical event committee reviewed procedural images and concluded that the diamondback 360 peripheral orbital atherectomy device possibly contributed to a myocardial infarction and stent thrombosis.No further information is available.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: 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: 20302006
• Report Number: 3004742232-2024-00334
• Device Sequence Number: 18359299
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210430(10)265806
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/25/2024

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: 04/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 265806
• 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: 09/09/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White