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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 09/03/2020

Event Type  Injury  

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 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 prior to distribution.The diamondback coronary orbital atherectomy system instructions for use manual states that pseudoaneurysm is a potential adverse event that may occur and/or require intervention.Csi id: (b)(4).

Event Description

Following an nstemi and surgical denial, a percutaneous coronary intervention procedure was performed to treat a calcified circumflex and a chronic total occlusion in the right coronary artery (rca).A diamondback coronary orbital atherectomy device (oad) was advanced, and five treatment passes were performed on low speed; however, the oad would not cross the lesion.During treatment, complex anatomy resulted in lack of support from the flex tip viperwire guide wire.The oad driveshaft and saline sheath became prolapsed against the wall of the left main (lm), and the oad stalled.The oad was removed, and a balloon was inserted; however, the balloon would not cross the lesion.The balloon was inflated one time proximal to the lesion and was removed.A guide catheter was inserted to provide support, and the balloon was reinserted; however, it would again not cross the lesion.A viperwire guide wire advance without flex tip was inserted for added support, the oad crossed the lesion, and additional treatment was performed in the circumflex artery (cx).Angiography was then performed for the first time during the procedure (due to the creatinine levels of the patient), and a pseudoaneurysm was noted in the lm.The patient was unaffected hemodynamically, and no treatment was performed to address the pseudoaneurysm.Stents were placed in the cx and proximal left anterior descending artery.Following the procedure, the patient was in stable condition and remained intubated following the prior nstemi.The pseudoaneurysm remained under observation.Per the opinion of the physician, the cause of the pseudoaneurysm was unknown, however the prolapse of the oad likely contributed.

• 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: 10520790
• MDR Text Key: 206523881
• Report Number: 3004742232-2020-00275
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220131(10)309349
• 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: 09/11/2020

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: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 309349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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): Hospitalization; Other
• Patient Age: 67 YR