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 Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was positioned at a lesion in the mid left anterior descending artery (lad) using glideassist.The oad was operated at low speed for one treatment pass, following which an angiogram was performed and confirmed that there was no issue.The oad was operated for a second treatment pass, following which an angiogram showed a perforation in the mid lad proximal to the lesion.The oad was removed from the patient, during which the guide wire was pulled back and wire access to the lad was lost.The lad was re-wired and a balloon was inflated for post dilation.A stent was then inserted but would not cross the proximal lad.Balloon angioplasty was performed again and the stent was reinserted but still would not cross.Post dilation was performed again with a non-compliant balloon and a guide catheter was inserted for support.The stent crossed the lesion and was deployed, however an angiogram still showed a perforation.A covered stent was then placed proximal to the first stent, and the final angiogram showed that the perforation was sealed.The vitals of the patient began to decrease and the patient presented with hypotension.A code was initiated and cardiopulmonary resuscitation was performed along with an echocardiogram.A pericardiocentesis was performed and 700cc of blood was drained and transfused back into the patient.Following a 15 minute code, the patient vitals were stabilized.A ventricular assist device was inserted and the patient was transferred to the intensive care unit where they remained in stable condition as of (b)(6) 2020.

Manufacturer Narrative

The oad was returned to csi for analysis with the guide wire engaged in the device.There was some observed dried, adhered biological material on the driveshaft and crown of the oad and on the guide wire spring tip.Resistance was felt when removing the guide wire from the driveshaft and handle assembly.It is possible that the material contributed to the reported event, however this could not be confirmed.Examination of the areas of adhered material did not reveal any damage that would have contributed to the material accumulation.The exact root cause and morphology of the accumulating material is unknown.When tested with the returned guide wire the device functioned as intended.At the conclusion of the device analysis investigation, the reported perforation could not be confirmed through analysis.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.The diamondback coronary orbital atherectomy system instructions for use manual states that perforation is a potential adverse event that may occur and/or require intervention.Results code: 4247 - suggested code is biological material present on device.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; st. paul, mn MN 55112
• MDR Report Key: 10691327
• MDR Text Key: 211713329
• Report Number: 3004742232-2020-00320
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220331(10)317115
• 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
• Report Date: 11/12/2020

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 Expiration Date: 03/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 317115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 54