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

Model Number DBEC-125

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Encephalopathy (1833); Perforation (2001); Ventricular Fibrillation (2130); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 11/15/2014

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient experienced a dissection and a perforation.The target lesion was located in the proximal circumflex artery.The physician treated the lesion using a csi coronary viperwire guidewire and a csi orbital atherectomy device (oad).The physician completed two runs at low speed and one run at high speed.The post-atherectomy angiogram revealed a dissection at the site of treatment.The physician was able to get a balloon across the dissection and performed three inflations.He then re-introduced the csi oad into the patient and completed one more run.Follow-up balloon angioplasty was performed and a post-angioplasty angiogram revealed a perforation.The patient developed cardiac arrest and ventricular fibrillation.The patient was placed on cardiopulmonary bypass and transferred to the operating room.In the operating room, the patient underwent a median sternotomy and repair of the circumflex perforation.The patient was transferred to the cardiovascular icu in critical condition.On post-operative day #2, the patient was found to have diffuse encephalopathy and a poor prognosis for neurological recovery.The patient was extubated and 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 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).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: 4327021
• MDR Text Key: 5213853
• Report Number: 3004742232-2014-00063
• 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: 12/05/2014

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: 10/31/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 113827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• 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): Required Intervention
• Patient Age: 67 YR