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 Bradycardia (1751); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2020

Event Type  Death  

Manufacturer Narrative

The oad was received for analysis.Dried, adhered fluid and suspected corrosion was observed on the driveshaft and crown.Examination of the area of adhered fluid did no reveal any damage.A guide wire was passed through the area with no resistance, so this is not considered a contributing factor in the reported event.No additional damage was observed on the oad.The oad was tested and functioned as intended with no abnormalities observed.Review of the downloaded device data did not reveal any issue with the oad that would have contributed to the reported events.At the conclusion of the device analysis, the reported events were unable to be conclusively confirmed.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.(b)(4).Csi id# (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the left anterior descending coronary artery (lad).The lad was moderately tortuous with 90% calcified stenosis in the mid to mid-distal lad.The lesion was wired with a non-csi guide wire with some difficulty, and an exchange was performed for the viperwire guide wire.The oad was advanced to the lesion using glideassist.Two treatments on low speed were performed.The oad was then advanced using glideassist to the mid/distal area of the lesion.Four treatments on low speed were performed, and no vessel issues were observed.The oad was repositioned to the mid-proximal lesion area, and two treatments were performed.The oad was removed, and a perforation was observed in the lad.The patient presented with mild shortness of breath.Balloon angioplasty and stent deployment were performed, but the perforation was not contained.An effusion was present.Additional balloon angioplasty and stenting were performed, and the perforation was contained.The lad was observed on imaging to be patent, however, diagonal and septal branches could no longer be seen via imaging.Pericardiocentesis was unsuccessful.The patient presented with pulseless ventricular tachycardia.Defibrillation was successful, resulting in sinus bradycardia with hypotension, and vasopressors were administered.Pericardiocentesis was again unsuccessful.The patient went into sinus tachycardia with no blood pressure, and cardiopulmonary resuscitation (cpr) was performed.The patient was intubated.The non-csi guide catheter was reinserted, and thrombosis was observed.Balloon angioplasty was performed.No flow was observed in the lad, and a thrombectomy was performed; however, no flow was still observed.After 30 minutes, there was no return of spontaneous circulation, cpr was discontinued, and the patient expired.In the opinion of the physician, the primary cause of death was acute stent thrombosis in the lad status post pulseless ventricular tachycardia while attempting pericardiocentesis, and the secondary cause of death was cardiac tamponade due to perforation.It was noted the patient had been appropriately heparinized prior to the procedure, and additional heparin was administered during the procedure.In the opinion of the physician, the lad had thrombosed during the initial event of pulseless ventricular tachycardia.

• 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: 10554336
• MDR Text Key: 207555241
• Report Number: 3004742232-2020-00278
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220531(10)326825
• 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: 09/18/2020

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: 05/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 326825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• 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: 85 YR