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

Device Problem Occlusion Within Device (1423)

Patient Problem Stenosis (2263)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

Event date is literature article published date successful management of recurrent iliofemoral venous in-stent stenosis (isr) with a drug coated balloon (dcb) xi xue, david w.Trost, akhilesh k.Sista clinical imaging (2018) 49 (2018) 184¿186.If information is provided in the future, a supplemental report will be issued.

Event Description

The present report describes a patient with recurrent right iliofemoral instent thrombosis failing multiple repeated percutaneous interventions finally successfully managed by drug-coated balloon (dcb) angioplasty.Patient with negative thrombophilia and malignancy work up initially presented with provoked right popliteal deep vein thrombosis (dvt) in 2004.Between 2004 and 2012, the patient suffered three repeated episodes of right iliofemoral dvt, with thrombosis extending from the right external iliac to the popliteal vein, despite having therapeutic inr on oral warfarin and subsequently transitioning to therapeutic subcutaneous enoxaparin injections per his hematologist-oncologist.Patient was referred to interventional radiology in 2012 for venoplasty and venous stenting.Between 2012 and 2016, he suffered eight additional repeated episodes of right iliofemoral deep vein occlusion, ranging from a focal 2 cm in-stent stenosis of the common femoral vein to total occlusion from the right external iliac to the popliteal vein, despite standard percutaneous treatments including pharmacomechanical thrombolysis, venoplasty, and multiple venous stenting/re-stenting with nitinol stents.A total of seven overlapping venous stents were deployed (between 2012 ¿ (b)(6) 2013) in total, spanning from the right external iliac to the central femoral vein which included 14x60mm protégé (x2 deployed to treat a near complete occlusion from right common iliac to femoral vein in (b)(6) 2013) and a 12x80mm protégé (x1 during treatment of isr from right common iliac to right femoral vein).The remaining stents were non-mdt.The pharmacomechanical thrombolysis system used included 15 cm trellis peripheral infusion system which was used during treatment when the 12x80mm protégé stent was placed.Trellis peripheral infusion system (15cm) was also used in a later procedure in (b)(6) 2013 to treat isr from right external iliac to femoral vein.A non-mdt stent was placed during this procedure.30cm trellis peripheral infusion system was used during another intervention in (b)(6) 2014 to treat complete occlusion from distal ivc to right common femoral vein, where a non-mdt was also placed.The average patency of the stents was five and half months, ranging from 2 weeks to 12 months.Prior to intervention in (b)(6) 2016 the patient was only symptom-free for 6 weeks.Physical examination on this presentation showed right lower extremity erythema, asymmetric 2+ pitting edema, and a shallow venous ulcer over the right medial malleolus.Moderate right lower extremity venous ectasia was also noted.Right lower extremity duplex ultrasound (us) showed central flow within the right external iliac stent but severe isr in the mid and peripheral aspect of the common femoral vein stent.The superficial venous system was also noted to be slightly ectatic but otherwise patent.Intraoperative venography showed severe (> 80%) isr within the common femoral venous stent.The right common iliac, central external iliac, and peripheral common femoral stents were patent.No acute thrombosis was identified.Initial angioplasty was performed using non-mdt devices once the stenosis was traversed.A 7× 60 mm in.Pact admiral drug-coated balloon was subsequently inflated within the stenotic region, followed by a 10 × 40 mm non-mdt balloon.<(><<)> 1:1 sizing was chosen to ensure complete apposition of the dcb, and the post-dcb 10 mm inflation was employed to maximize luminal diameter.Post-procedural venography demonstrated improved stent patency and brisk flow without evidence of collaterals.6-month and subsequent 12-month follow-ups using right lower extremity duplex ultrasound showed the stent to be widely patent.On physical exam, the right medial malleolus venous ulcer was well healed without interval development of new ulcers.

• Brand Name: TRELLIS-6 PERIPHERAL INFUSION SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7576973
• MDR Text Key: 110325592
• Report Number: 2183870-2018-00316
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 05/08/2018
• 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: 56 YR