MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); CORONARY ATHERECTOMY DEVICE

Model Number GWC-12325LG-FLP

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2023

Event Type  Injury  

Manufacturer Narrative

The material inspection report for this guidewire 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.H6 health effect - clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that slow/no flow is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).

Event Description

Following multiple low-speed treatments of a heavily calcified, 85% stenosed, extremely tortuous lesion in the bend of left anterior descending (lad) artery using coronary orbital atherectomy device (oad) via antegrade radial approach, no reflow in the vessel was observed.Angiographic imaging did not reveal dissection.Balloon angioplasty and stent application were performed but the issue persisted.The oad crown jumped forward, but it was unknown if it made contact with the viperwire advance coronary guide wire spring tip.A wire bias at the lad bend was noted.The oad was removed over the viperwire and the viperwire spring tip was observed to be fractured and resting in the distal part of the lad.The fractured component was successfully snared.Vessel flow was restored using drug-eluting stent, heart pump, and intravenous antiplatelet medication.The patient was stable.

• 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: 18418196
• MDR Text Key: 331588150
• Report Number: 3004742232-2023-00295
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005187
• UDI-Public: 013085252800518717250731108617952
• 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: 12/29/2023

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 Model Number: GWC-12325LG-FLP
• Device Lot Number: 8617952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female