MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED 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); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 09/27/2016

Event Type  Death  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The lot number was not recorded and could not be obtained.(b)(4).Device discarded by facility.

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient coded while using the csi orbital atherectomy device (oad).Prior to this procedure, the patient had been to the facility twice in the week prior for a mycardial infarction and other health related issues.During one of those procedures, the patient had tried to get off the table and coded.The right coronary artery (rca) was completely occluded prior to and during the procedure.The target lesion was 1mm in length, 80% stenotic and located in the left main (lm) artery.The patient was administered precedex at the beginning of the procedure for sedation.After receiving precedex, the patient's blood pressure (bp) was 40/30 and the patient was hemodynamically unstable throughout the procedure.The physician used a 7fr introducer sheath, a bmw guide wire and a 2.5mm exchange balloon to access the lesion.The physician advanced a csi viperwire guide wire across the lesion and the oad was loaded onto it.The physician performed three runs at low for 25 seconds, one run on high for 25 seconds and another run on high for 37 seconds.The physician followed-up atherectomy by performing balloon angioplasty and stent deployment in the lm artery.Adenosine and nipride were administered to help stabilize the patient's bp but the patient went into respiratory distress.Cardiopulmonary resuscitation (cpr) was performed and the patient was stabilized.The patient was taken to recovery in stable condition, but expired later that evening after going into cardiac arrest.A request for additional information was made, but only angio images were provided.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: jacob mellem ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6058014
• MDR Text Key: 58411812
• Report Number: 3004742232-2016-00121
• 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: 10/21/2016

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: 09/27/2016
• Initial Date FDA Received: 10/26/2016
• 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; Hospitalization; Life Threatening