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 Cardiac Arrest (1762); Death (1802); Perforation (2001); Ventricular Fibrillation (2130)

Event Date 11/21/2014

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient expired.The target lesion was located in the proximal left circumflex artery (lcf).The physician treated the lesion using a csi coronary viperwire guidewire and a csi coronary orbital atherectomy device (oad).The physician completed 2 runs on low speed and 1 run on high speed.Following treatment, the patient developed cardiac arrest.The patient was intubated and a temporary pace maker was placed.The post-atherectomy angiogram revealed a perforation in the left main coronary artery (lmca).A 15x3 stent was placed in the lmca and a 18x2.5 stent was placed in the lcf.Ventricular fibrillation and asystole occurred and the patient status continued to decline.The patient expired on (b)(6) 2014.

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 was not review as the lot number is unknown.The lot number was not recorded or saved by the facility.(b)(4).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: 4340746
• MDR Text Key: 5142052
• Report Number: 3004742232-2014-00064
• 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: 12/17/2014

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 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
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/18/2014
• 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
• Patient Age: 74 YR
• Patient Weight: 67