MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE; CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687); Pericardial Effusion (3271); Asystole (4442); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/14/2022

Event Type  Death  

Manufacturer Narrative

The material inspection report for this guide wire 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.

Event Description

A ventricular assist device was placed for treatment of an eccentric focal lesion in the severely stenosed, distally very tortuous, left anterior descending (lad) artery.A teleport microcatheter was used for a wire exchange, and the viperwire advance guide wire with flex tip was placed for a planned retrograde treatment.When the diamondback 360 coronary orbital atherectomy device (oad) was being advanced the wire migrated proximally.The manufacturer representative advised to advance the wire distally prior to performing a treatment.The physician retracted the oad crown proximally to perform treatment antegrade.Glide assist was activated to advance the wire distally.However, the wire was unable to be advanced to the original position.The physician was advised to ensure a minimum of 10mm distance between the oad and the opaque wire tip.A successful treatment was performed on low speed.While performing the second treatment, force appeared to have been applied and the crown jumped across the mid lesion.The crown made contact with the wire.The physician was advised to stop multiple times while continuing treatment.The oad was then stopped, and a wire tip fracture had occurred.The physician questioned wire position.The wire was removed; however, the wire tip fragment remained in vivo.Angiographic imaging was performed, and no perforation or dissection was observed.The patient began to experience chest pain.Angiographic imaging was performed a second time and revealed wire tip fragment was not in the lad.Imaging confirmed a perforation had occurred.The tip fragment was visualized in the pericardium.The vessel was wired, and a balloon was delivered to perform tamponade at the perforation site, followed by a covered stent.A drug eluting stent was then placed.Pericardiocentesis was performed.Angiography revealed a slowed or stopped perforation.The devices, including a ventricular assist device, were removed.An echocardiogram revealed reduced effusion.As the patient was being prepared to be removed from the table, they experienced chest pain and hypotension.An unsuccessful attempt to remove blood from the pericardium was made.An echocardiogram revealed a large effusion.The physician repositioned the drain and removed a large amount of blood.The physician then checked to determine the status of the coronary bleed due to the return of effusion.The coronary arteries revealed no visual bleed; however, blood pressure continued to drop.Left ventricle angiography revealed no inflow to the left ventricle and the aortic valve was not opening.A temporary pacing device was performing pacing.The echocardiogram was showing asystole.There was no pulse detected.Emergent life saving measures were taken including having performed cardiopulmonary resuscitation (cpr) for approximately 30 minutes.The patient expired.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 15984151
• MDR Text Key: 305488769
• Report Number: 3004742232-2022-00295
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)231031(10)404643-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 404643-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White