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 Hematoma (1884); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Thrombus (2101); Perforation of Vessels (2135); Dizziness (2194)

Event Date 01/23/2020

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.The diamondback coronary orbital atherectomy device instructions for use states that perforation is a possible adverse event which can occur with use of the diamondback coronary orbital atherectomy device.(b)(4).

Event Description

During a procedure with a diamondback coronary orbital atherectomy device (oad), a perforation occurred in the right coronary artery (rca) with pericarditis.The target, 99% stenosed, severely calcified lesion was located in an area of the right coronary artery that ranged from 2.5 to 4.0 millimeters in diameter, and the rca was complex with severe angulation.A perforation occurred and was treated with balloon tamponade and two covered stents.Additional orbital atherectomy was then performed, which resulted in frank perforation of the coronary artery.The perforation was treated with balloon tamponade and protamine.Emergency pericardiocentesis was performed, and 700 cc of fluid was removed from the pericardial space and placed directly back in the venous system.During pericardiocentesis, the needle was introduced into the pleural spaced and then moved back into the pericardial space.The patient left the procedure with a pericardial drain.A few hours after the procedure, the patient experienced pleuritic chest pain thought to be secondary to pericarditis, and the patient experienced temporary st elevations in v1 to v4.The patient received medication for the pericarditis.The pericardial drain was removed on (b)(6) 2020, and the patient experienced acute diaphoresis, dizziness, hypotension, and shock.A circumferential pericardial effusion and left pleural effusion was observed, and a sternotomy was performed.There was significant hematoma and blood clotting between the sternum and pericardium.The pericardium was tense, and there was evidence of trauma to the myocardium.250cc of blood was removed from the pericardial space without evidence of active bleeding.400cc of blood was drained from the left pleural space, and a large blood clot was discovered along the mediastinal pleural tissues with no active bleeding identified.200cc of blood was removed from the right pleural space with no active bleeding identified.Three chest tubes were placed and the patient was transferred to the intensive care unit.The next day, the patient was extubated and hemodynamically stable.The mediastinal and pleural chest tubes were intact and draining.The chest tubes remained until drainage subsided.An echocardiogram was performed prior to chest tube removal to assess for fluid.After the chest tubes were removed, a limited transthoracic echocardiogram showed trivial pericardial effusion.A chest x-ray showed minimal left pleural effusion which did not requiring thoracentesis.The patient had a brief episode of atrial fibrillation while hospitalized, which was treated with medication.The patient was ready for discharge as of (b)(6) 2020.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9738391
• MDR Text Key: 190049053
• Report Number: 3004742232-2020-00041
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/21/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 76