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

Model Number DBP-200SOLID145

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

Patient Problems Embolism (1829); Vascular System (Circulation), Impaired (2572)

Event Date 06/05/2019

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 the reported oad was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a procedure using a diamondback peripheral orbital atherectomy device (oad), embolization occurred.The target lesion was a long, diffuse, 100% occluded lesion located from the superficial femoral artery (sfa) bifurcation to the mid sfa with collateralized back filling of the distal portion of the lesion.The vessel was 6 mm in diameter and was not tortuous.The lesion was crossed for a contralateral femoral approach, and the guide wire was located in the true lumen.When atherectomy treatment was initiated, it sounded like the oad was in the subintimal plane during the first treatment pass.The patient felt some discomfort in the thigh during the first pass, and the oad was removed and imaging performed.The proximal portion of the lesion was then treated with balloon angioplasty.The physician made the decision to treat the distal portion of the lesion with atherectomy, and the treatment was performed with the same oad that was used in the proximal portion of the lesion.Following atherectomy, the oad was removed, and imaging showed brisk flow through the vessel.A drug coated balloon was inserted and inflated, and the post-balloon imaging showed slower flow through the vessel than the prior imaging.Imaging was performed in the lower leg, and there appeared to be a distal emboli in the tibial peritoneal trunk (tpt).The patient was transferred to an operating room for surgical removal of the emboli.The surgical removal of the emboli was successful, and the emboli was considered to be the cause of the slow flow by the physician.However, there were additional flow issues in the distal vessels when the emboli was removed, and the physician was unable to verify why the flow issue persisted following the embolectomy.The cause of the emboli was unable to be confirmed.It was reported that the patient was doing well one day post operation.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 8734255
• MDR Text Key: 149186342
• Report Number: 3004742232-2019-00162
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBP-200SOLID145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention