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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 Aneurysm (1708); Fever (1858); 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 an interventional cardiologist practicing in spain who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (26 procedures), femoral arteries (32 procedures), ilio-femoral arteries (16 procedures), popliteal arteries (22 procedures), infra-popliteal arteries (19 procedures), and renal arteries (29 procedures). The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (6 procedures) and for stent post dilatation in the peripheral vasculature (6 procedures). This interventional cardiologist also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (23 procedures), femoral arteries (41 procedures), ilio-femoral arteries (19 procedures), popliteal arteries (18 procedures), infra-popliteal arteries (12 procedures), and renal arteries (33 procedures). The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures) and for stent post dilatation in the peripheral vasculature (61 procedures). Related to the evercross pta balloon catheter, two aneurysm events are reported during use for dilatation of stenoses in the femoral arteries and popliteal arteries. Three fever events are reported during use for dilatation of stenoses in the iliac arteries. One venous thromboembolism event is also reported. The aneurysm events are reported to be very concerning. The fever events and venous thromboembolism event are reported to be not at all concerning. One aneurysm event (during percutaneous treatment) is reported to be device related. One fever event is reported to be device related and attributed to local effects. The venous thromboembolism is also reported to be device related and anticoagulant treatment is mentioned. Related to the fortrex pta balloon catheter, one artery perforation or rupture event is reported to have occurred during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Two hematoma events are reported during dilatation of stenoses in the iliac arteries and popliteal arteries; and also, during stent post dilatation in the peripheral vasculature. Three haemorrhage events are reported during dilatation of stenoses in the femoral arteries, during treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and during stent post dilatation in the peripheral vasculature. The artery perforation or rupture event is reported to be very concerning but not related to the device. The hematoma events were reported to be not at all concerning but one is reported as being related to the device itself and was given local treatment. The haemorrhage events are reported to be somewhat concerning and one is reported to have been related to the device itself and local pressure treatment was applied.
 
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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 Key9009739
MDR Text Key162336547
Report Number2183870-2019-00443
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSP
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
0 Patients were 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

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