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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Perforation of Vessels (2135); Renal Impairment (4499)

Event Date 01/22/2021

Event Type  Death  

Manufacturer Narrative

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.During investigation, the physician stated the primary cause of death was vasodilatory shock due to severe sepsis with secondary causes of cardiorespiratory failure, acute renal failure, and acute limb ischemia.The opinion of the physician is that the csi device 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.Csi id# (b)(4).

Event Description

On (b)(6) 2021, a procedure was performed using a diamondback pluto coronary orbital atherectomy device (oad) after review of results from a prior procedure, which took place on (b)(6) 2021.During the procedure on (b)(6) 2021, rotational atherectomy was used, and a large calcium fragment shifted into the ostial left anterior descending artery (lad).During the procedure on (b)(6) 2021, the glideassist function of the oad was used via radial access to position the oad crown distal to the shifted calcium.Two distal to proximal treatment passes were performed on low speed for 25 seconds each.Very little engagement with the calcium was heard.No angiography was performed.A high-speed treatment was initiated, and the patient experienced chest pain after approximately five seconds.Treatment was stopped, and angiography showed a perforation in the proximal to mid-section of the lad.Balloon angioplasty was applied, and a stent was deployed to resolve the perforation.Left femoral access was gained, and an impella device was placed.Pericardiocentesis was unsuccessful in draining fluid from behind the right atrium.The patient was stable, and the impella was removed.The patient was intubated for a transesophageal echocardiogram.The patient still had active bleeding behind the right atrium on the evening of (b)(6) 2021.Additional surgery was performed on (b)(6) 2021 and (b)(6) 2021 to drain fluid from behind the right atrium.The patient developed an acute kidney injury due to shock secondary to coronary perforation and tamponade.The patient underwent dialysis on (b)(6) 2021 and remained in the hospital.Life support was withdrawn on (b)(6) 2021, and the patient expired on (b)(6) 2021.

• 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 11345112
• MDR Text Key: 232454260
• Report Number: 3004742232-2021-00048
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220831(10)342357-1
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 342357-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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): Death; Required Intervention
• Patient Age: 75 YR