FDA Adverse Event Death Summary report: N

DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

MDR report key: 6973482 · Received October 24, 2017

Report

Report Number: 3004742232-2017-00107
Event Type: Death
Date Received: October 24, 2017
Date of Event: September 27, 2017
Report Date: October 24, 2017
Manufacturer: CARDIOVASCULAR SYSTEMS, INC.
Product Code: MCX
PMA / PMN Number: P130005
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A DISSECTION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). AN ADDITIONAL LESION NEEDED TO BE TREATED, BUT THE PHYSICIAN WAS HAVING DIFFICULTY PULLING THE DEVICE BACK. WHILE ATTEMPTING TO PULL THE DEVICE BACK PROXIMALLY, THE GUIDE CATHETER PROLAPSED INTO THE VESSEL AND CAUSED A DISSECTION. THE PATIENT STATUS STARTED TO DECLINE AND THE PATIENT CODED. THE OAD WAS REMOVED FROM THE PATIENT AND MULTIPLE STENTS WERE DELIVERED. AN IMPELLA VENTRICULAR ASSIST DEVICE WAS INSERTED INTO THE PATIENT AT THIS POINT, BUT THE PATIENT WAS UNABLE TO RECOVER AND EXPIRED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS DENIED BY THE FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
752574	DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM	CORONARY ATHERECTOMY DEVICE	MCX	CARDIOVASCULAR SYSTEMS, INC.	DBEC-125	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Death