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

Model Number DBEC-125

Device Problems Off-Label Use (1494); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

The reported device was discarded by the facility and was not returned for analysis.Therefore, the exact root cause of the event remains unknown.However, based on the reported information, it appears the device was used in an off-label manner; the device was operated within a previously placed stent.The diamondback 360® coronary orbital atherectomy system instructions for use states that use of the oas is contraindicated when the target lesion is within a stent.Ultimately, based on the information received, the cause of the reported event could not be conclusively determined.The device history record for the reported oad was unable to be reviewed, as the lot number was not provided.Csi id: (b)(4).

Event Description

The diamondback coronary orbital atherectomy device (oad) was used during a procedure for treatment of a 50% restenosed stent in the right coronary artery (rca).The distal portion of the stent was under-expanded and malposed.A balloon was initially inflated inside the restenosis and distal malposed portion of the stent.Following multiple attempts with cutting balloons and laser atherectomy, an intravascular ultrasound catheter still could not be advanced into the stented lesion.The oad was then selected for use due to the lesion location and since the patient was not a bypass candidate.Three atherectomy treatments were successfully performed on low speed, but during the fourth treatment, the oad became stuck.The stent was tangled over the oad, and the driveshaft and stent were removed together.Additional balloon inflations were performed, and another stent was placed.At the conclusion of the procedure, a residual stenosis remained, and the vessel showed excellent flow.An echocardiogram was performed to ensure there was no pericardial effusion; no effusion was observed.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 8921526
• MDR Text Key: 155243763
• Report Number: 3004742232-2019-00221
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 80 YR
• Patient Weight: 63