MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Occlusion (1984); Thrombus (2101); Vascular Dissection (3160)

Event Date 05/02/2014

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a dissection occurred and the patient required an intra-aortic balloon pump.The target lesion was 20mm in length and was located in the mid-left anterior descending (lad) artery which was 80% occluded.The physician used an ebu guide catheter and a bmw guide wire to access the lesion.He exchanged the bmw guide wire for a csi viperwire guide wire and advanced it to the treatment site.A csi orbital atherectomy device (oad) was then loaded onto the viperwire and advanced just proximal to the lesion.The physician completed one run at low speed for 20 seconds.During the second run at low speed, the crown seemed to jump distally in the lesion as it was still tight.The physician pulled the device back and then performed a third run at high speed with no difficulty.A post-atherectomy angiogram revealed a dissection in the mid-lad.A balloon was advanced to the dissection and inflated for 60 seconds.The physician followed-up balloon angioplasty by placing a 3.5x33mm stent at the dissection.Another angiogram revealed that the lesion had been successfully treated and the dissection had been resolved; however, the physician noted a small stenosis in one of the diagonal arteries off of the lad.The patient then began to experience chest pain.The physician attempted to pass a 2.0 balloon across the diagonal, but was unsuccessful.He then used a 1.5 balloon, crossed the stenosis in the diagonal and inflated the balloon.At this point, the patient exhibited more symptoms and thrombus began forming from the left main artery and into the left lad artery.Multiple different modalities were attempted to remove the thrombus, during which the patient coded.Emergency measures were attempted for 90 minutes.Eventually, the patient was placed on a balloon pump and transferred to the icu.The patient expired in the icu on (b)(6) 2014.Additional information has been requested of the facility, but none has been received.

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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).Device discarded by facility.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3838313
• MDR Text Key: 4413884
• Report Number: 3004742232-2014-00027
• 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: 05/22/2014

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 Expiration Date: 04/30/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 97815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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