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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Ecchymosis (1818); Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis (2100); Thrombus (2101)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: median age.Sex: majority gender.Event date is literature article published date.(b)(4).Http://doi.Org/10.1007/s00270-018-1918-z.If information is provided in the future, a supplemental report will be issued.

Event Description

Addressing infra-popliteal thrombus in iliofemoral dvt: the criss-cross technique cardiovasc intervent radiology 2018 duarte c.Rego, ahmed khairy sayed ahmed, gerard j.O¿sullivan purpose the purpose of this work was to describe the results of a technique of simultaneous antegrade and retrograde vascular access (¿¿criss-cross¿¿) to the popliteal vein to achieve venous recanalization in patients with acute, extensive, iliofemoral dvt with concomitant popliteal and calf vein thrombosis.Materials and methods seven patients were treated using this technique, in three patients as a bailout option after failed posterior tibial vein puncture and in four as a first option.Antegrade popliteal venous access was performed according to the usual technique using duplex ultrasound (dus) guidance and thrombolysis (cdt), or thrombectomy (pmt) was performed.Following this, the retrograde sheath was placed under dus guidance, a tibial vein was selectively catheterized and cdt, and/or a pmt was performed.Results three patients underwent isolated cdt, another three had associated pmt, and one patient underwent iliofemoral pmt and catheter thromboaspiration of the popliteal and calf veins.Median thrombolysis duration was 72 h (24¿72 h).Sir grade iii thrombolysis was achieved in six patients and grade ii in one patient.All patients underwent subsequent stenting of their iliac vein lesions.Minor complications were observed in two patients (ecchymosis), while one patient developed a hematoma on the popliteal fossa.Conclusion this ¿¿criss-cross¿¿ technique represents a safe alternative to the distal (anterior or posterior tibial) vein access both as a bailout option after failed distal venous access as well as a primary approach due to its potential advantage of clearing larger thrombus volume.Experience in ultrasound-guided popliteal vein puncture is crucial to avoid complications.Event description: seven patients were treated using this technique.There was one case of right leg dvt.All patients had an acute dvt.One patient had a pancreatic cancer and another one was taking oral contraceptives.All patients had extensive dvt with thrombus extending from the iliacs to the below knee veins; one of the patients had proximal extension of her dvt into the inferior vena cava (ivc).Half of the patients had associated pulmonary embolism(pe) as assessed on preoperative ctv.An ivc filter was placed in all but one patient.Three patients underwent isolated cdt, two patients had associated pmt with trellis one patient had associated pmt with a non-medtronic device and another patient had iliofemoral trellis¿ pmt and calf vein thromboaspiration with catheter (did not undergo cdt due to intraoperative onset of neurologic deficit, hemorrhagic was afterwards excluded).Three of the six patients who underwent pmt also had catheter clot aspiration.In those patients undergoing primary or concomitant cdt, the median thrombolysis duration was 72 h (24¿72 h).Following thrombolysis, control venograms revealed sir grade iii thrombolysis ([95% clot removal) in six patients and grade ii (50¿95% clot removal) in one patient.The underlying lesion was an iliac stenosis in four patients and an iliac occlusion (acute on chronic dvt) in three patients.All patients had pta and stenting of these iliac lesions with the need, in two patients, to extend stenting to the femoral vein due to residual inflow stenosis.Local bleeding complications were observed in three patients; two had minor bleeding (ecchymosis) associated with vein access, and one developed a calf hematoma that did not result in a compartment syndrome but was the responsible for early (7 days) recurrent iliofemoral dvt due to poor inflow (popliteal vein compression).After venous recanalization, all patients were kept on anticoagulation (6 on vitamin k antagonists and 1, with cancer, on low-molecular weight heparin).During follow-up (median 4 months), all patients maintained stent and vein patency except for the patient who had early recurrent thrombosis; after repeated thrombolysis and pmt of iliofemoral dvt, at day 7 after the index procedure, this patient with pancreatic cancer presented with another recurrent thrombosis at day 37 that was deemed irreversible.

Manufacturer Narrative

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

• Brand Name: TRELLIS-6 PERIPHERAL INFUSION SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN; 4600 n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7734354
• MDR Text Key: 115531696
• Report Number: 2183870-2018-00404
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K130904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• 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: 08/08/2018
• 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: 60 YR