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 Problem Perforation of Vessels (2135)

Event Date 11/26/2020

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.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.Patient age is approximate.Csi id: (b)(4).

Event Description

Orbital atherectomy was selected for treatment of heavily calcified lesions in a patient with a preexisting aneurysm in the left anterior descending artery (lad).Three treatment passes with a diamondback peripheral orbital atherectomy device (oad) were administered distal-to-proximal in the lad.The treatments were performed distal to the aneurysm site.Angiography was performed and revealed that the initial treatments were not effective; four additional treatment passes were performed at high speed.Due to physician technique, treatment was inadvertently administered in a more proximal location than intended.This resulted in treatment of the aneurysmal segment.Oct was performed and revealed that a perforation had occurred at the aneurysm site.Angioplasty and stent placement were performed to resolve the perforation.An ultrasound, angiography, and intravenous ultrasound confirmed that extravasation had ceased.The patient was in good condition following procedure.Four days following the procedure, the patient expired.In the opinion of the physician, the cause of death was low oxygen saturation levels secondary to thrombus caused by the stent.The drainage method and administration of anticoagulation medications also contributed to the patient's death in the opinion of the physician.

• 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: 11054953
• MDR Text Key: 223058144
• Report Number: 3004742232-2020-00396
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005794
• UDI-Public: (01)10852528005794(17)220531(10)326012
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

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 Lot Number: 326012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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: 87 YR
• Patient Weight: 37