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

Model Number DBEC-125

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Low Blood Pressure/ Hypotension (1914); Stenosis (2263); Loss of consciousness (2418); Vascular Dissection (3160)

Event Date 09/22/2014

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a dissection and patient death occurred.The target lesion was calcified, 80-90% stenotic, 90mm in length and was located in the left circumflex artery.The physician used a 6fr introducer sheath, prowater guidewire and an ebu 3.5 guide catheter to access the lesion.The physician placed a transvenous pacemaker before beginning atherectomy.The physician advanced a csi viperwire guidewire across the lesion and loaded a csi orbital atherectomy device (oad) onto the guidewire.The physician performed two runs at low speed and one run at high speed in the proximal segment of the lesion.The physician then performed two runs at low speed and two runs at high speed in the distal segment of the lesion.After removing the oad from the patient, the patient became hypotensive.An angiogram revealed a proximal vessel dissection and no flow distally in the circumflex.A 2.5x12mm balloon was inserted and inflated at the site of the dissection.The patient then became unresponsive with further hypotension.Acls (advanced cardiovascular life support) protocol ensued including intubation, multiple defibrillations and chest compressions.After extended measures and discussion with the patients family, all resuscitative efforts were stopped and the patient expired.

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 was not reviewed as the lot number is unknown.(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: 4180478
• MDR Text Key: 5099116
• Report Number: 3004742232-2014-00049
• 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: 10/15/2014

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: 09/22/2014
• Initial Date FDA Received: 10/17/2014
• 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: 75 YR
• Patient Weight: 66