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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.(b)(4).

Event Description

The target lesions were severely calcified lesions in the right coronary artery (rca) numbers one to three.Rca number one was 90% stenosed and rca numbers two and three were chronic total occlusions (cto).The lesion in rca number one was successfully treated with a diamondback 360 coronary orbital atherectomy (oad) via right transfemoral approach.Following dilation of the lesion in rca number three at 14 atmospheres (atm) using abbott trek 2.5 x 30mm balloon, the trek balloon was replaced with viperwire advance coronary guide wire.The oad was advanced on glideassist to the lesion in rca number three and low-speed treatment began.The spinning stopped immediately after starting with a high-pitched sound.Low-speed treatment was again attempted, but the same high-pitched sound recurred, and spinning stopped.Oad removal was attempted, but it was stuck.Holding the oad handle while straightening the oad driveshaft facilitated its removal.In the opinion of the physician, the oad crown got stuck due to advancing in the very tight lesion.Contrast imaging was performed which revealed a perforation.As the perforation was on the myocardial side, there was no blood accumulation in the pericardial sac and there were no abnormalities in the electrocardiogram.The physician decided to discontinue the procedure and observe the patient.The patient remained stable four days after the treatment and no further complications occurred.Coronary artery bypass graft (cabg) is planned in the future as originally planned.Percutaneous coronary intervention (pci) was performed due to patient's request.

Event Description

Additional information was received on 03april2024 indicating that the patient was discharged from the hospital on (b)(6) 2024 and took coronary artery bypass graft (cabg) at another hospital on (b)(6) 2024.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.(b)(4).

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• 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: 19027984
• MDR Text Key: 339204806
• Report Number: 3004742232-2024-00146
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 436679-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 05/10/2024
• Supplement Dates FDA Received: 04/26/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• 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): Hospitalization; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG