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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Non specific EKG/ECG Changes (1817); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2021

Event Type  Death  

Event Description

Orbital atherectomy was selected for treatment of the left circumflex, with a 90-degree bend present in the left main artery and treatment of the obtuse marginal (om) artery which had a 120-degree bend.The diamondback coronary orbital atherectomy device (oad) was operated in the 120-degree bend for one treatment pass and the crown jumped forward slightly.Glideassist mode was activated to advance the oad to treat the om and after three treatment passes an attempt was made to remove the oad but it became stuck in the vessel.Glideassist was activated and the oad was powered off.Glideassist was activated again and the oad was manually pulled back.An attempt was then made to advance the oad forward via glideassist mode, however this was unsuccessful.A wire was inserted to free the crown, however due to the 120-degree bend the wire could not advance around the crown.The fluid sheath was cut in an attempt to insert the sheath over the crown, however this was also unsuccessful.The driveshaft and guide wire were cut.Additional attempts were made to retrieve the remaining fragments, including re-wiring the vessel, inserting guide catheters over the oad driveshaft, and changing the sheath size, however due to the angulation the vessel, difficulty was encountered and the attempts were unsuccessful.The guide wire and oad were manually pulled, and the oad fractured, leaving the guide wire in the oad crown stuck in the circumflex artery.St changes were observed during the procedure.Due to the patient's unstable baseline and the location of the fragments behind the pulmonary artery, the patient was turned down for surgery to remove the fragments and they were left in vivo.Two days later the patient expired.

Manufacturer Narrative

The reported oad was received at csi, engaged on the guide wire at the distal driveshaft section.The driveshaft sheath and driveshaft were confirmed to have been cut, and the entire driveshaft was stretched out and fractured at the distal end.Scanning electron microscopy analysis of the driveshaft fracture faces showed some evidence of tension from the driveshaft having been forcibly pulled to fracture.Review of the device data log revealed stall events, which may have occurred at the time of the crown becoming stuck or during troubleshooting to remove the device, although this could not be confirmed.When tested, the oad functioned as intended.At the conclusion of the device analysis, the report that the oad had fractured was confirmed and the identified fractures were hypothesized to be due to the applied forces used in attempts to remove the oad.The report of the oad getting stuck in the vessel and the crown jumping could not be confirmed through analysis, and the cause was unknown.After multiple follow-up attempts to the site, the cause of death remains unknown.It is not known if the csi device caused or contributed to the patient's death.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 guide wire event during this procedure has been reported under 3004742232-2021-00431.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE,
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 13110887
• MDR Text Key: 282916333
• Report Number: 3004742232-2021-00430
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)231031(10)231031
• 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: 12/29/2021

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 Expiration Date: 10/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 402686-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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; Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American