MAUDE Adverse Event Report: AVINGER, INC. PANTHERIS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number A200

Device Problems Poor Quality Image (1408); Cut In Material (2454)

Patient Problem Thromboembolism (2654)

Event Date 12/05/2016

Event Type  No Answer Provided  

Event Description

A short focal lesion at the superficial femoral artery (sfa) was successfully treated using the pantheris catheter.After the atherectomy procedure, an arteriogram of the distal sfa was performed, and distal sfa occlusion from embolus was found.The occlusion was not there on the pre- angiogram run off.A spectranetics laser was used to soften the occlusion and then it was ballooned to resolve the flow issues.Further review found another embolus at the tibioperoneal trunk (tpt).Laser and percutaneous transluminal angioplasty (pta) of the tpt was performed to restore flow to the lower leg.The physician had not used an embolic protection device during the atherectomy procedure.No serious patient injury was reported.

• Brand Name: PANTHERIS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): AVINGER, INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): AVINGER, INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jennifer cleto ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417046
• MDR Report Key: 6179756
• MDR Text Key: 62522901
• Report Number: 3007498664-2016-00012
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/15/2017
• Device Model Number: A200
• Device Catalogue Number: A200
• Device Lot Number: 160615003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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
• Treatment: 0.014" GUIDEWIRE; PTA BALLOON; SPECTRANETICS LASER
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR