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 Fistula (1862); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a review of medical journal articles, csi found an article titled "orbital atherectomy-induced coronary fistula" in the journal of the american college of cardiology in june of 2016.It was discovered that an orbital atherectomy-induced fistula occurred.The article reported that, "orbital atherectomy was performed successfully and followed-up with balloon angioplasty and stent placement.Post-procedure, persistent contrast staining was noted around the proximal circumflex, but echocardiography showed no pericardial effusion.The patient was discharged three days later with resolution of her symptoms." "however, the patient presented two months later with progressive dyspnea, edema and chest tightness.The patient was found to have moderate pericardial effusion and bilateral pleural effusions.Despite diuresis, the patient had persistent hypoxemia.Catheterization revealed patent proximal to mid circumflex stents and a fistula between the proximal/mid circumflex artery and the coronary sinus/venous system.The fistula was successfully excluded with the placement of two covered stents." csi has requested additional information, but none has yet been received.

• 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: 5911698
• MDR Text Key: 53398378
• Report Number: 3004742232-2016-00095
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2016

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: 08/01/2016
• Initial Date FDA Received: 08/29/2016
• 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): Other; Required Intervention
• Patient Age: 71 YR