MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE); CORONARY ATHERECTOMY DEVICE GUIDEWIRE

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used to treat an 80% stenosed lesion in moderately tortuous severely calcified vessel in right coronary artery (rca) via femoral access.The vessel diameters were 4.0mm distal and 4.5mm proximal and was primary wired with viperwire advance guidewire without any difficulty.Six low-speed treatments were performed in the distal area and glide assist was used in the proximal area treatments.While spinning, the viperwire did not come close to the oad.The physician decided to exchange the viperwire with an abbott whisper extra support guide wire to place a stent.During removal of viperwire, imaging showed the viperwire tip was dislodged in a very small branch off the distal rca and was not moving.A second physician was called, and it was decided to leave the viperwire fragment in place since no snaring device would fit in the small artery and the artery did not feed any vessel.In the opinion of the physician, the rca branch was too small that the viperwire tip got stuck in it during atherectomy when the oad spun, and got fractured when the viperwire was retracted during removal efforts.No wire bias was observed.The viperwire was exchanged with abbott whisper extra support guide wire.Three stents were placed followed by post dilation with ballooning to complete the procedure.The patient was stable and did not experience further complication and medical intervention.

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 this guide wire 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Type of Device: CORONARY ATHERECTOMY DEVICE GUIDEWIRE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st. paul 55112
• MDR Report Key: 19080733
• MDR Text Key: 339878177
• Report Number: 3004742232-2024-00161
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other