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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Aneurysm (1708); Death (1802); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 07/09/2019

Event Type  Death  

Manufacturer Narrative

Details of this event were provided by the physician, csi field staff, and a medwatch report (b)(4), which was received by csi on 6 august 2019.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.Additional information has been requested from the clinic regarding the return of the device, but additional information has not been received.If additional information is received or if the device is received for analysis, a supplemental report will be submitted.Csi id#: (b)(4).Additional information regarding another csi device used in this procedure is documented in mdr 3004742232-2019-00206.(related csi id: (b)(4).

Event Description

During a procedure, the coronary diamondback orbital atherectomy device (oad) became stuck in the vessel, and a dissection and perforation were seen on imaging following removal of the oad.The patient expired during treatment of the perforation.The target lesions were located in the right coronary artery (rca) (ostial, proximal, mid, and distal), the left anterior descending (lad), and the left circumflex artery (lcx).A temporary pacemaker was placed and tested.Treatment of the lesions in the rca was successful, and the viperwire was removed and replaced with a guide wire that was inserted into the left main artery (lm).A workhorse wire was used to cross the lesion located in the lcx and was then exchanged for a viperwire.The oad was re-inserted into the patient, and glide assist was used to cross the lesion prior to treatment in order to treat the lesion from a retrograde approach.Two treatments were performed for approximately 20-25 seconds, and the oad became stuck.The glideassist function would not activate, and multiple attempts to remove the device using manual efforts and balloons proved unsuccessful.The driveshaft of the oad was cut, and the original guide wire was removed to obtain another arterial access site.The guide wire was inserted into the lm,, where multiple attempts were made to advance a guideliner over the oad and remove it, and the oad was successfully removed in this manner.An angiogram was performed, and a small aneurysm was noted.Additional imaging was performed, and multiple injections of contrast revealed that a perforation had occurred.A stent was placed without success to prevent cardiac tamponade.A pericardiocentesis was performed with a possible right ventricle puncture.Blood was unable to be drained from the pericardial space.The patient became hypotensive, and developed bradycardia which led to cardiac arrest.Multiple doses of epinephrine were administered, and a drip was initiated.Cardiopulmonary resuscitation was performed for approximately 20 minutes while additional unsuccessful attempts to drain the blood were made.The angiogram showed worsening of the perforation and extravasation of fluid in the pericardium, along with the lack of return of spontaneous circulation.The patient was pronounced dead by the physician.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 8870980
• MDR Text Key: 153646753
• Report Number: 3004742232-2019-00203
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)210531(10)270623
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 270623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: 89 YR
• Patient Weight: 75