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

Model Number VPR-SLD2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress by the original manufacturer.A supplemental report will be submitted when the device analysis is completed.It was reported to csi that the patient expired around the time period of 14 feb.The opinion of the physician was that the primary cause of death was a groin bleed due to the large bore devices used during the procedure and no csi device caused or contributed to the patient death.(b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used to treat the mid right coronary artery (rca).Multiple treatment passes were performed, with angiograms taken following the second and fourth treatments.One additional treatment pass was performed at high speed, and a subsequent angiogram confirmed flow.The oad was then moved to the distal rca and the guide wire was repositioned in the posterior descending artery.The blood pressure of the patient decreased and an angiogram indicated no flow to the distal vessel.The lack of flow was attributed to hypotension.The patient showed no pressure and intubation and cardiopulmonary resuscitation were performed.Medications were administered to treat the low blood pressure and a stent was placed in the mid rca.Post dilatation angiograms showed restored flow in the rca.A balloon pump was inserted followed by a ventricular assist device, and during this time epinephrine was administered and compressions were started.An echocardiogram and ultrasound were performed and ruled out a dissection or perforation.The blood pressure of the patient was noted to stabilize with small doses of epinephrine, leading the physicians to conclude that the patient had experienced an allergic reaction to the viperslide lubricant.A reaction to the contrast dye was considered, however this did not present during previous angiograms.The only allergy stated on the chart of the patient was penicillin.Continued epinephrine treatment and subsequent steroid administration increased the blood pressure and the patient remained stable.Further left and right coronary angiograms showed that both sides of the heart were patent with sufficient flow, and the pressure of the patient remained consistent as they were transferred to intensive care for observation.The patient was extubated and stable as of 12 feb.

Manufacturer Narrative

Updated fields: b4, g3, g6, h1, h2, h3, h6, h10.The investigation of this product was performed by the original manufacturer, fresenius kabi.Fresenius kabi provided the following analysis conclusion: one sample was received for the evaluation of this complaint.The sample arrived without the outer pouch.Due to this fact the sample could not be investigated.The certificate of conformity indicates no anomalies; all test results were within limits and in conformance with valid specifications.This batch is manufactured according to gmp guidelines.There were no deviations reported during production and quality control of this batch.This batch met all specification requirements.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: 11472966
• MDR Text Key: 239410108
• Report Number: 3004742232-2021-00071
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005125
• UDI-Public: (01)30852528005125(17)211031(10)10NL2944
• 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: 04/01/2021

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: 10/31/2021
• Device Model Number: VPR-SLD2
• Device Lot Number: 10NL2944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 104