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

Model Number DBEC-125

Device Problem Positioning Problem (3009)

Patient Problems Perforation of Vessels (2135); Loss of consciousness (2418)

Event Date 12/20/2023

Event Type  Injury  

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a 90% stenosed, heavily calcified lesion in left anterior descending (lad) artery via femoral access.Three treatments on low and two treatments on high were performed.Following wiring and balloon angioplasty of the diagonal for bifurcation stenting, the patient was found unresponsive.Angiographic imaging revealed perforation in proximal lad.Cardiopulmonary resuscitation (cpr) and intubation were performed on the patient and extracorporeal membrane oxygenation (ecmo) was placed.In the opinion of the physician, high oad speed, wire bias and guide forcing oad to the top of lad led to perforation.To resolve the perforation, a covered stent was applied, and the patient was admitted to the operating room for emergency bypass surgery.The surgery was completed with no further complications.Ecmo has been removed and the patient extubated and neurologically intact.The patient was stable and discharged.

Manufacturer Narrative

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.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 the reported guide wire could not be reviewed, as the lot number was not provided.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.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18499444
• MDR Text Key: 332726651
• Report Number: 3004742232-2024-00083
• Device Sequence Number: 1
• Product Code: MCX
• 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
• Report Date: 01/11/2024

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 Model Number: DBEC-125
• Device Lot Number: 502157-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Treatment: VIPERWIRE CORONARY GUIDE WIRE - UNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 84 KG