MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)

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 evercross pta balloon catheter.Survey results received for a cardiothoracic surgeon practicing in (b)(6) who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (2 procedures), femoral arteries (1 procedures), ilio-femoral arteries (3 procedures), popliteal arteries (1 procedures), infra-popliteal arteries (2 procedures) and renal arteries (3 procedures).The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (2 procedures) and for stent post dilatation in the peripheral vasculature (4 procedures).This cardiothoracic surgeon also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (2 procedures), dilatation of stenoses in the femoral arteries (1 procedures), dilatation of stenoses in the ilio-femoral arteries (2 procedures), dilatation of stenoses in the popliteal arteries (1 procedures), dilatation of stenoses in the infra-popliteal arteries (3 procedures), and dilatation of stenoses in the renal arteries (4 procedures).The fortrex pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (3 procedures), and for stent post dilatation in the peripheral vasculature (5 procedures).Related to the evercross pta balloon catheter, two artery perforation or rupture events are reported during dilatation of stenoses in the ilio-femoral arteries and during stent post dilatation in the peripheral vasculature.Four events of bleeding requiring transfusion are reported to have occurred during dilatation of stenoses in the renal arteries.Five hematoma events are reported to have occurred during dilatation of stenoses in the iliac arteries, and popliteal arteries; and during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.The artery perforation or rupture events are reported to be somewhat concerning.The hematoma and bleeding requiring transfusion events are reported to be not at all concerning.Four of the bleeding requiring transfusion events are reported to have been device related but the patient is reported to have been on blood thinners.Five of the hematoma events are reported to have been device related.The artery perforation or rupture events are reported to have not been device related at all.Related to the fortrex pta balloon catheter, three haemorrhage events are reported during dilatation of stenoses in the iliac arteries, and renal arteries.Four venous thromboembolism events are reported during dilatation of stenoses in the femoral arteries, ilio-femoral arteries.The haemorrhage events were reported to be somewhat concerning and the venous thromboembolism events were reported to be not at all concerning.One haemorrhage event is reported to be related to the device, but it is reported the patient was on blood thinners.One venous thromboembolism event is reported to be device related but it is reported multiple passes with the catheter were conducted.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• 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: 9009001
• MDR Text Key: 162349483
• Report Number: 2183870-2019-00442
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142654
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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