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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 Reocclusion (1985); Thrombosis (2100); Pseudoaneurysm (2605)
Event Date 01/01/2005
Event Type  Injury  
Manufacturer Narrative

Mean age = 76. 6. Mean gender (141 men and 76 women). Study title: midterm outcomes of stent placement for long-segment iliac artery chronic total occlusions: a retrospective evaluation in a single institution kaichuang ye, md, xinwu lu, phd, md, minyi yin, phd, md, weimin li, md, ying huang, phd, md, xintian huang, md, min lu, md, and mi¿er jiang, md http://dx. Doi. Org/10. 1016/j. Jvir. 2013. 02. 038. 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 purpose of this journal article is to assess the clinical and patency results of stent placement for long-segment iliac artery chronic total occlusions (ctos). It is reported that evercross pta balloon catheters were used during the study. Periprocedural in-stent thrombosis occurred in nine patients and was treated successfully with catheter-directed thrombolysis. In 12 patients with iliac artery restenosis, repeat endovascular angioplasty treated the lesions successfully, and femorofemoral bypass was performed in 2 patients. In 2 patients who refused further therapy, restenosis was treated with medical therapy without clinical impairment during follow-up. Femoral pseudoaneurysms occurred in two patients, and brachial pseudoaneurysms occurred in three patients, and all were treated with open surgical repairs.

 
Manufacturer Narrative

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

 
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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 Key6394721
MDR Text Key69618747
Report Number2183870-2017-00130
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received02/10/2017
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: 03/10/2017 Patient Sequence Number: 1
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