MAUDE Adverse Event Report: COVIDIEN VIANCE CROSSING CATH; CATHETER, PERCUTANEOUS

Catalog Number VNC-SD-150

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician attempted to use a viance catheter to treat a moderately calcified lesion with little tortuosity and 100% stenosis in the distal right popliteal artery.The ifu was followed and the device was prepped without issue.It was reported the device was unable to cross through the lumen.The viance catheter was unable to re-enter the peroneal.The physician used a non-medtronic 0.014" guide wire to re-enter the vessel.Two stents were deployed in the chronic total occlusion(cto) area but they both thrombosed mid procedure and were balloon angioplastied.The stents remain in the patient.Heparin was administered before and after the stent deployment and thrombolytic was administered via the arterial sheath.The patient was also put on dual anti platelet therapy as per hospital protocol.The patient is reported to be doing well and has since been discharged from the hospital.

• Brand Name: VIANCE CROSSING CATH
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7929701
• MDR Text Key: 122477626
• Report Number: 2183870-2018-00454
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K113589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2019
• Device Catalogue Number: VNC-SD-150
• Device Lot Number: A562372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Date Device Manufactured: 11/29/2017
• 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