MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Material Separation (1562)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2023

Event Type  Death  

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.The material inspection report for this guidewire 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.H6 health effect - suggested clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that slow or no reflow phenomen is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a 99% stenosed, diffuse left anterior descending (lad) lesion via right femoral access with a 6 french sheath.Using the viperwire advance with flex tip coronary guide wire, four low-speed and one high-speed oad treatments were completed.Impella support was previously considered but due to patient body habitus and peripheral artery disease (pad), it was not possible.During removal of the oad with glideassist, the physician felt resistance.Upon removal, the viperwire spring tip was observed to be fractured.At this time, the patient experienced bradycardia and hypotension.Angiographic imaging showed no reflow caused by distal bed overflow of particulate following atherectomy treatment.The patient went into ventricular tachycardia and code protocols were performed.Balloon angioplasty and stent placement were performed in the lad, but flow was not re-established.The patient expired.In the opinion of the physician, heavily diseased lad was the primary cause of patient death.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; saint 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: 17670900
• MDR Text Key: 322512139
• Report Number: 3004742232-2023-00219
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250228(10)477565-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 477565-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Treatment: VIPERWIRE ADVANCE GUIDEWIRE LOT 476761-1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 147 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White