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 Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiogenic Shock (2262); Diaphoresis (2452)

Event Date 10/26/2021

Event Type  Injury  

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for treatment of the left anterior descending artery.The oad was traversed more than 3 mm per second, and at the lesion the oad jumped forward.Treatment was stopped after 30 seconds and the oad was removed.Imaging revealed a non-flow limiting dissection and the area was pre-dilated with a balloon and stent placement was performed.Intravascular ultrasound revealed a hematoma outside the stent.The wire and guide catheter were removed.Later that evening, the patient went into cardiogenic shock and became hypotensive and diaphoretic.An echocardiogram revealed a perforation was the cause of the cardiogenic shock.The patient also had cardiac tamponade.Placement of stents and pericardial drains were performed to resolve the perforation and tamponade events.The patient was discharged on (b)(6) 2021 without further complications.

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.Per the physician, the hematoma and dissection events may have been caused by the csi device, however the physician stated that the patient was prone to dissections.The physician declined to offer an opinion as to what caused the perforation, cardiogenic shock, tamponade and atrial fibrillation events.(b)(4).

Manufacturer Narrative

Updated fields: a3, a6, b4, g3, g6, h2, h10 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 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: 12835857
• MDR Text Key: 280961928
• Report Number: 3004742232-2021-00381
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)230831(10)393314-1
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

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: 08/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 393314-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2021
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White