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

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.

• Brand Name: EVERCROSS 035
• 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: 6394721
• MDR Text Key: 69618747
• Report Number: 2183870-2017-00130
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 03/10/2017
• 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
• Date Manufacturer Received: 02/10/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR