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 Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2022

Event Type  Injury  

Event Description

Percutaneous coronary treatment of a diagonal branch was attempted via radial access and non-atherectomy treatment with a 5fr guide catheter since the patient's pressure waveform was ventricularized and slightly dampened with use of a 6fr guide catheter.The physician then opted to obtain right femoral access with a 6fr sheath for additional support.The left anterior descending artery (lad) was wired with a viperwire in preparation for ostial and mid lad atherectomy with a diamondback coronary gen 2 orbital atherectomy device (oad).The mid lad lesion was heavily calcified with a 70%, long stenosis.The ostial lesion was mildly calcified but approximately 95% stenosed.Glideassist was used to position the oad crown past the ostial lesion.The mid lad lesion was treated on low and high speed for 20 seconds with 30 seconds of rest after the initial treatments.The lad was open after atherectomy.Approximately one minute later, the ostial segment was treated for 20 seconds on low speed only.At this time the patient's pressure and heartrate fell, and atropine and phenylephrine were given.However, the patient decompensated to ventricular tachycardia.A code was called, and advanced cardiovascular life support protocol was initiated.The ostium of lad was dilated two to three additional times during the progression of the code, and the vessel shut down.A 3.0mm stent was placed in the proximal lad, and flow was re-established.Prior to stenting, an impella was placed in the left femoral artery for left ventricular support.The patient eventually returned to normal sinus rhythm and stable blood pressure on epinephrine and norepinephrine drips.The patient was intubated during the code as well.The patient is neurologically intact.Pressors were weaned down, and the patient was still intubated with impella support as of (b)(6) 2022.The patient had improved significantly.

Manufacturer Narrative

(b)(4).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 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 physician was concerned there was a dissection in the proximal segment of the lad after atherectomy.During review by another physician, a left main dissection was noted, and the opinion of that physician was that the guide catheter caused the dissection prior to atherectomy, but the dissection had not been noticed prior to atherectomy.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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 14083517
• MDR Text Key: 289061706
• Report Number: 3004742232-2022-00088
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)231231(10)415421-1
• 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: 04/12/2022

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: 12/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 415421-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White