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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 Extravasation (1842); Reocclusion (1985); Patient Problem/Medical Problem (2688)
Event Date 05/25/2017
Event Type  Injury  
Manufacturer Narrative
Age/date of birth: average age. Sex: majority gender. Date of event: event date is literature article published date balloon angioplasty with selective stenting strategy in treatment of hemodialysis related central vein occlusive lesions international angiology (2017) vol 36, no. 5 - 462-466 doi: 10. 23736/s0392-9590. 17. 03817-2. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The aim of this study was to evaluate the safety and efficacy of balloon angioplasty and selective stenting in treatment of symptomatic central vein occlusive lesions (cvol) in patients with upper extremity hemodialysis access. This study comprised of 74 patients with symptomatic cvol underwent endovascular therapy. Fifty-four (54) % of the population was male with a mean age of 49. 7 years. Of the 74 patients, venography showed 29 cases of complete occlusion and 45 stenotic lesions. Twenty-nine (29) lesions were located on the right side and 46 on left side. Vein location of these lesions was auxiliary vein (4), subclavian vein (27) and brachiocephalic vein (43). In 11 cases, the occluded segment could not be traversed. For the remaining 63 patients; pta alone was carried out in 46 cases and bare metal stenting was performed in 17 patients. Symptomatic improvement was reported in all the patients with no major periprocedural morbidity or mortality except puncture site extravasation (6 patients), none of which required surgical intervention. Five (5) patients were lost to follow-up within the one year follow-up period. Repeated interventions were carried out when symptoms recurred. Patients with recurrent symptoms were treated with repeat balloon angioplasty, and two patients had stent placement. Pta was the initial treatment option for cvol with reported technical success of 85. 1% and 73% for those patients treated with balloon angioplasty alone. In the current study, stents were placed in 17 (27%) patients. Stents were deployed in case of residual stenosis 50% or recurrence within 3 months following balloon angioplasty. In conclusion, balloon angioplasty with selective stenting strategy is a safe and effective treatment method for cvol in short term. Enhanced follow-up and repeated interventions are required for better durability.
 
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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 Key6881261
MDR Text Key86981862
Report Number2183870-2017-00407
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
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: 09/20/2017 Patient Sequence Number: 1
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