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

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 02/01/2023

Event Type  Death  

Event Description

Difficulty was experienced when advancing a non-csi guide wire and a balloon through the left main (lm) artery into the left anterior descending (lad) artery and maintaining wire position.The vessel was then direct wired with a viperwire flex tip guide wire.Difficulty was experienced when advancing the non-csi wire and the viperwire.Three treatments were performed advancing from the lm to the lad using a diamondback 360 coronary orbital atherectomy device (oad).The oad was removed, an over the wire (otw) balloon was placed, and wire exchange with a non-csi wire was performed.During this time, the patient's blood pressure was slowly decreasing.Following the removal of the otw balloon, imaging was performed and revealed a perforation at the treatment site in the lad.A balloon was then positioned, inflated and removed.An unsuccessful attempt was made to cross the lesion with a covered stent.A balloon was then positioned and inflated followed by placement of a covered stent at the perforation site.The perforation had resolved; however, the patient's blood pressure was low.Medication and a blood transfusion were administered, and the blood pressure improved.The perforation was observed to be leaking again.An nc balloon was placed and inflated for two minutes, resolving the perforation.Blood flow in the lad returned to normal to complete the procedure.An echocardiogram was performed and revealed no pericardial effusion.The patient was transferred to the intensive care unit in critical but stable condition.The patient later expired.The cause of death could not be confirmed.

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 16477951
• MDR Text Key: 310602483
• Report Number: 3004742232-2023-00053
• 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
• Report Date: 03/03/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Race: White