MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Myocardial Infarction (1969); Vascular Dissection (3160)
Date of Event	12/28/2020
Type of Reportable Event	Death
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the proximal circumflex artery via femoral access.The severely calcified lesion was 12mm in length with a vessel diameter of 2.5mm.After one treatment on low speed, a type d dissection occurred.The oad was removed, and balloon angioplasty and stent placement were performed.The vessel looked decent following stent deployment.The patient became hypotensive.Dopamine, epinephrine and levophed were administered.An impella heart pump was inserted.The heart pump was then removed.The patient also experienced atrial fibrillation with rapid ventricular response during stent positioning and deployment.Amiodarone was administered but did not convert the arrhythmia.Cardioversion was performed, and the cardioversion was successful in returning the patient to a normal sinus rhythm.The opinion of the physician was that the dissection led to the hypotension and arrythmia.The patient was in critical condition and was admitted to the intensive care unit.The patient remained hemodynamically unstable and experienced worsening bradycardia and pulseless electrical activity.A temporary pacemaker was placed.The patient coded, and sinus rhythm was able to be restored.The patient was transferred back to the intensive care unit and pulseless electrical activity continued intermittently.A do not resuscitate was signed by the patient's family, and hemodynamic support was discontinued.The patient expired on (b)(6) 2020.The causes of death were reported to be bradycardia and pulseless electrical activity.Additional information received from the clinical events committee indicated that a myocardial infarction (mi) occurred and is possibly related to orbital atherectomy.Mi was not reported by the site.Subject id: (b)(6).
Additional Manufacturer Narrative
Additional information was received related to previously submitted mdr.Cardiovascular systems incorporated has transitioned to a new complaint handling system and no longer has access to submit follow-up mdrs using esubmitter/webtrader.This mdr is being filed from our new system using the as2 gateway with reference to the previously reported manufacturer report number in h10.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information received, the investigation determined that the reported patient myocardial infarction, vascular dissection, arrhythmia, and death appear to be related to operational context.In this case it is possible that the reported patient myocardial infarction, vascular dissection, arrhythmia, and death are a result of the patient¿s disease severity and/or use techniques employed; however, since the device was not returned this could not be confirmed.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the proximal circumflex artery via femoral access.The severely calcified lesion was 12mm in length with a vessel diameter of 2.5mm.After one treatment on low speed, a type d dissection occurred.The oad was removed, and balloon angioplasty and stent placement were performed.The vessel looked decent following stent deployment.The patient became hypotensive.Dopamine, epinephrine and levophed were administered.An impella heart pump was inserted.The heart pump was then removed.The patient also experienced atrial fibrillation with rapid ventricular response during stent positioning and deployment.Amiodarone was administered but did not convert the arrhythmia.Cardioversion was performed, and the cardioversion was successful in returning the patient to a normal sinus rhythm.The opinion of the physician was that the dissection led to the hypotension and arrythmia.The patient was in critical condition and was admitted to the intensive care unit.The patient remained hemodynamically unstable and experienced worsening bradycardia and pulseless electrical activity.A temporary pacemaker was placed.The patient coded, and sinus rhythm was able to be restored.The patient was transferred back to the intensive care unit and pulseless electrical activity continued intermittently.A do not resuscitate was signed by the patient's family, and hemodynamic support was discontinued.The patient expired on (b)(6) 2020.The causes of death were reported to be bradycardia and pulseless electrical activity.Additional information received from the clinical events committee indicated that a myocardial infarction (mi) occurred and is possibly related to orbital atherectomy.Mi was not reported by the site.Subject id: (b)(6).

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 21944696
• Report Number: 3004742232-2025-00110
• Device Sequence Number: 9056506
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220930(10)345903-1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 06/04/2025

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: 09/30/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 345903-1
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2020
• 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: Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic