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

Model Number DBEC-125

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id:(b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used for treatment of a 95% stenosed, severely calcified, tortuous lesion in the distal left main (lm) coronary artery into circumflex (cfx) artery via radial approach.After three 20-second treatments it sounded like torque control activated.A fourth treatment was attempted in a less tortuous area, but the crown stopped spinning.The oad was removed.The nose length was intact but bent.Post dilation with a non-abbott balloon followed.A type c dissection was observed.In the opinion of the physician, severe vessel calcification, tortuosity and tightness contributed to the dissection.As no images were taken after the atherectomy it is not known if the dissection occurred after the atherectomy before balloon angioplasty or after.Stent placement was performed to resolve the dissection.The patient was stable.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use user manual states that vascular dissection is a potential adverse event that may occur and/or require intervention with use of the system.The oad was returned with the guide wire not engaged.There is a fractured driveshaft filar at the proximal edge of the crown and adhered biological material on the tip and crown section.The adhered material on the driveshaft crown section prevented the returned 0.012 inch wire from passing through.After removal of the occluded section of driveshaft, the wire passed through the remaining driveshaft and handle assembly without issue.When tested, the oad functioned as intended.Scanning electron microscope (sem) analysis was unable to identify clear evidence of fatigue failure due to mechanical polishing of the fractured filar faces but confirmed that the filar fracture occurred at the weld location within the crown.Driveshaft flexing at the weld location can initiate a fatigue failure.Although sem analysis did not show clear fatigue, it is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.The exact root cause of the driveshaft fracture is undetermined.The diamondback 360® coronary orbital atherectomy system instructions for use user manual (92-10044-01 rev b) states the following warnings: performing treatment in excessively tortuous or angulated vessels or bifurcations may result in vessel damage or device failure requiring retrieval.Never use force to advance the spinning crown as vessel perforation may occur.If any resistance to crown travel is felt, reposition the crown away from the lesion, immediately stop treatment, and use fluoroscopy to assess the vessel for any complications.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).

• 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; 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: 18909036
• MDR Text Key: 337730506
• Report Number: 3004742232-2024-00126
• Device Sequence Number: 1
• Product Code: MCX
• 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,Followup
• Report Date: 04/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 506777-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 199 KG
• Patient Race: White