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 Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Perforation of Vessels (2135)

Event Date 08/08/2017

Event Type  Death  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The lot number was not recorded and could not be obtained.(b)(4).

Event Description

It was reported that during a coronary orbital atherectomy procedure, a perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 90% stenotic and was located in the left anterior descending (lad) artery.An impella ventricular assist device was utilized during the procedure and inserted prior to atherectomy.The physician used a crossing guide wire to access the lesion and then exchanged for a csi viperwire guide wire.The oad was loaded onto the wire and advanced to the site of the lesion.The physician performed two runs at low speed for 15 seconds each run.The physician then performed one run at high speed for 10 seconds.Post-atherectomy angiography revealed a perforation.The physician performed balloon angioplasty and stent deployment to resolve the perforation.The patient was stable, but upon removing the impella device, the patient decompensated.The physician re-inserted the impella device, but the patient continued to go into ventricular fibrillation and ventricular tachycardia.After three hours of emergency measures, the patient expired.Additional information has been requested, but none has yet been received.

• 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: jacob mellem ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6834622
• MDR Text Key: 84249046
• Report Number: 3004742232-2017-00086
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2017

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: Physician
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/31/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death