MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Fever (1858); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the ever cross pta balloon catheter.Survey results received for an interventional radiologist practicing in italy who within the last 12 months used an ever cross pta balloon catheter for dilatation of stenoses in the iliac arteries (3 procedures), femoral arteries (8 procedures), popliteal arteries (8 procedures), and infra-popliteal arteries (8 procedures).The ever cross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures).This interventional radiologist also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (2 procedures), dilatation of stenoses in the femoral arteries (6 procedures), dilatation of stenoses in the popliteal arteries (6 procedures), and dilatation of stenoses in the infra-popliteal arteries (6 procedures).Related to the ever cross pta balloon catheter, three fever events are reported during use for dilatation of stenoses in the femoral arteries, popliteal arteries and infra-popliteal arteries.Two infection events are reported during use for dilatation of stenoses in the femoral arteries, popliteal arteries, and infra-popliteal arteries.One pseudoaneurysm event is reported during use for dilatation of stenoses in the iliac arteries.These three events are reported to be somewhat concerning.All fever events are reported to be device related and occurred in diabetic patients.The pseudoaneurysm event is reported to be device related but can possibly be attributed to procedural error.The infection events are reported to have not been device related at all.Related to the fortrex pta balloon catheter, one fever event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries.One inflammation event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries.One pseudoaneurysm event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries.These three events were reported to be somewhat concerning.These events were reported to be device related but it is reported for the fever and inflammation events the patient was diabetic and there was procedural error associated with the pseudoaneurysm event.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 9127840
• MDR Text Key: 161694094
• Report Number: 2183870-2019-00470
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• 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