MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

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

Patient Problems Death (1802); Hematoma (1884); Hemorrhage, Subdural (1894); Sepsis (2067); Perforation of Vessels (2135); No Code Available (3191)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a procedure using a diamondback orbital atherectomy device (oad), a perforation occurred, and the patient later passed away.An 80% stenosed, heavily calcified lesion was treated in the right coronary artery (rca).Three treatment passes were performed on low speed and one treatment pass was performed on high speed.An acute, type iii coronary perforation was observed, and a 3.0x20mm balloon was inflated to occlude flow.Two covered stents and one drug-eluting stent were placed, resolving the perforation.The drug-eluting stent was somewhat deformed from the calcification at the lesion site but was patent.The was a small to moderate pericardial effusion with intrapericardial hematoma observed, but there was no evidence of cardiac tamponade.After stent placement, slow flow was observed, and adenosine was administered.Final angiography showed optimal results.The patient was transferred to the intensive care unit after the procedure.Three days later, the patient passed away due to a bilateral subdural bleed.It was believed the bleed was caused by anticoagulation from the covered stent placement.

Manufacturer Narrative

Csi id# (b)(4).

Event Description

During a procedure using a diamondback orbital atherectomy device (oad), a perforation occurred, and the patient later expired.An 80% stenosed, heavily calcified lesion was treated in the right coronary artery (rca).Three treatment passes were performed on low speed and one treatment pass was performed on high speed.An acute, type iii coronary perforation was observed, and a 3.0x20mm balloon was inflated to occlude flow.Two covered stents and one drug-eluting stent were placed, resolving the perforation.The drug-eluting stent was somewhat deformed from the calcification at the lesion site but was patent.There was a small to moderate pericardial effusion with intrapericardial hematoma observed, but there was no evidence of cardiac tamponade.After stent placement, slow flow was observed, and adenosine was administered.Final angiography showed optimal results.The patient was transferred to the intensive care unit after the procedure with some hemodynamic concerns.An iapb was in place, and the patient went into sepsis.Three days after the procedure, the patient became unresponsive and a ct scan showed a bilateral subdural bleed.The patient's pupils were blown, and the patient expired.It was believed the bleed was caused by anticoagulation from the covered stent placement.

Manufacturer Narrative

Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8365811
• MDR Text Key: 136984810
• Report Number: 3004742232-2019-00060
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

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: Health Professional
• Device Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/22/2019; 02/19/2019
• Supplement Dates FDA Received: 02/28/2019; 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 70 YR