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U.S. Department of Health and Human Services

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

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Blood Loss (2597)
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 italy 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 beenon 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.
 
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Brand NameEVERCROSS 035
Type of DeviceCATHETER, 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 Key9008977
MDR Text Key162334799
Report Number2183870-2019-00441
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
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