MAUDE Adverse Event Report: COVIDIEN TRELLIS-6 PERIPHERAL INFUSION SYSTEM; CATHETER, CONTINUOUS FLUSH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Hematoma (1884); Unspecified Infection (1930); Renal Failure (2041); Thrombus (2101); Blood Loss (2597)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Date of publication online (month year valid) journal article title: outcomes and predictors of failure of iliac vein stenting after catheter-directed thrombolysis for acute iliofemoral thrombosis efthymios d.Avgerinos, md, zein saadeddin, md, adham n.Abou ali, md, yash pandya, md, eric hager, md, michael singh, md, george al-khoury, md, michel s.Makaroun, md, and rabih a.Chaer, md, msc, pittsburgh, pa copyright 2018 by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvsv.2018.08.014.If information is provided in the future, a supplemental report will be issued.

Event Description

142 with a previous history of dvt were identified for this study, patients were treated with various combinations of thrombolytic techniques in the common and external iliac.A protégé everflex and trellis was used with 6 non-medtronic devices for thrombectomy and stenting.It was reported the in some instances the stent was difficult to deploy.The patients presented post procedure with access site hematoma requiring surgical evacuation, one epidural hematoma compressing the spinal canal, requiring surgical evacuation, arrhythmias, transient acute-on-chronic renal failure, bleeding requiring blood transfusion 5 systemic bleeds include 1 case of minor gastrointestinal bleeding, 3 cases of severe haemoglobin drop with no apparent source, dvt recurred in 9 patients, 4 had incomplete thrombolysis.In three of these, reintervention was performed, and an additional stent was placed; two were successful.

• Brand Name: TRELLIS-6 PERIPHERAL INFUSION SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 8419793
• MDR Text Key: 138768365
• Report Number: 2183870-2019-00127
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/14/2019
• 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: 46 YR