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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 03/02/2021

Event Type  Death  

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 material inspection report 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.Csi id: (b)(4).

Event Description

The coronary viperwire guide wire was engaged with a 95% stenosed lesion in the left main, and the wire was placed in a branch of the left anterior descending artery (lad).The spring tip of the wire appeared to be about 7 cm distance distal to the lesion.Multiple treatment passes were performed with a diamondback coronary orbital atherectomy device (oad) on low speed.During the first treatment pass, the crown engaged the lesion and resistance was encountered.The physician applied pressure and the crown jumped forward 5-6 cm, engaging the spring tip of the guide wire.The oad was able to be retracted to continue treatment, and it could not be confirmed via imaging if the wire had fractured.An additional treatment pass was performed at high speed, and a perforation was observed in the left main via angiography.The pressure of the patient decreased, they presented with chest pain, and pharmacologic therapy was administered.A covered stent was placed in the lad and the perforation was improved, however extravasation was still observed.A second covered stent was placed in the left main and circumflex, which jailed the ramus and the lad.Balloon angioplasty and a drug eluting stent were placed to recover the circumflex, and a balloon pump was inserted.Upon removal of the viperwire guide wire from the patient, the tip was confirmed to be missing.The wire fragment was unable to be retrieved as it was located in the inaccessible jailed section of the lad.At the conclusion of the procedure, the patient was transferred to the coronary care unit in stable condition.Upon review of films post-procedure, it was determined that the wire fracture likely occurred during the first treatment pass when the oad crown jumped forward and contacted the wire spring tip, and the perforation may have been related to the operation of the oad on high speed over the fractured guide wire.The balloon pump was later replaced with a ventricular assist device.The patient presented with hypertension related to the events of the procedure, which negatively impacted the kidneys and liver.The patient was also hypoxic.The patient expired on (b)(6), and the opinion of the physician was that the patient death resulted from complications related to the hypertension.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 11519131
• MDR Text Key: 240787235
• Report Number: 3004742232-2021-00085
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)220131(10)310222
• 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: 03/18/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 310222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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: 82 YR
• Patient Weight: 104