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

Model Number GWC-12325LG-FLP

Device Problem Positioning Problem (3009)

Patient Problems Pseudoaneurysm (2605); Vascular Dissection (3160)

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 material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided.Csi id# (b)(4).

Event Description

During a procedure, a diamondback coronary orbital atherectomy device (oad) and viperwire guide wire were used to treat a target lesion in the mid left anterior descending artery (lad).The target lesion was a type b, 75% stenosed lesion.The target lesion was treated with five treatment passes at 80krpm.It was initially reported that a dissection was enlarged at the proximal site of the lesion and became a coronary pseudoaneurysm.It was noted that the event was thought to be related to a strong wire bias with the viperwire guide wire.A perfusion balloon was used to minimize the pseudoaneurysm and a covered stent was implanted.After the procedure, the pseudoaneurysm was noted on a pre-ivus image, however, the pseudoaneurysm had been enlarged after atherectomy.The patient condition following the procedure was good.

• 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; 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: 8712118
• MDR Text Key: 148423706
• Report Number: 3004742232-2019-00157
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/19/2019
• 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: 71 YR