MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Stenosis (2263); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age.Sex: majority gender.Date of event: available online.Journal article title: "catheter-directed thrombolysis through anterior tibial vein for treating acute extensive deep venous thrombosis." haiyang wang, ms, xiaotong qi, phd, hailong luo, md, qian zhang, ms, yikuan chen, phd, and jianming sun, phd, chongqing, china.Copyright 2018, by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvsv.2018.04.013, journal of vascular surgery: venous and lymphatic disorders, wang et al, 685, volume 6, number 6.If information is provided in the future, a supplemental report will be issued.

Event Description

The objective of this study was to evaluate the feasibility, efficacy, and safety of catheter-directed thrombolysis (cdt) through an anterior tibial vein approach for acute extensive lower extremity deep venous thrombosis (dvt).Because right iliac vein compression syndrome (ivcs) is uncommon and the angle between the right common iliac vein and the inferior vena cava (ivc) is small, dvt of the right lower extremity was an indication for filter placement with floating thrombus in the iliac vein or thrombus extending into the ivc.For safety, a retrievable or temporary ivc filter was usually implanted before cdt.The seldinger technique was used to puncture the anterior tibial vein.The guidewire was advanced through the needle after puncture.A 5f or 6f introducer sheath was then implanted under local anaesthesia.The guidewire and angiographic catheter were passed together through the femoral vein to the ivc.All patients received additional balloon dilation to crush thrombus.A 10- to 12-mm percutaneous transluminal angioplasty admiral xtreme balloon was navigated through the femoral vein to the common iliac vein; it was then inflated slowly to 8 to 10 atm pressure, which can shatter the thrombus and relieve the stenosis in the iliac veins.Similarly, an 8- to 10-mm balloon was applied in the proximal femoral veins.A 4f infusion catheter with multiple holes was advanced to cover the thrombosis segments after balloon dilation.A thrombolytic drug was micropumped through the infusion catheter at a rate of 600,000 to 900,000 iu per 24 hours.In the case of serious bleeding complications, catheter related infection, complete dissolution of thrombus, or no change on two successive venography studies, thrombolysis was ceased.Balloon dilation and self-expandable stent were used to treat patients with ivcs after cdt.A 10- to 12-mm balloon was navigated through the anterior tibial vein to the occlusion or stenosis, and the balloon was inflated for 3 minutes under 10 to 12 atm pressure to relieve the occlusion or stenosis.If the residual stenosis was >50% from multiple projections, a 12- to 14-mm self-expandable stent (including protégé gps) was placed.The diameter of the stent was selected to be 10% to 15% larger than the adjacent patent veins, and the length exceeded the occlusion or stenotic lesion by at least 2 cm.If a stenotic lesion was found in the junction of the ivc and the common iliac vein, the proximal segment of the stent was extended approximately 0.5 cm into the ivc.For patients with stent restenosis and secondary thrombosis, a covered stent was used to isolate it from band formation of veins, to enhance local support force of the stent.The technical success was 94.40% (118/125) for all patients.Four of seven failures were due to patients¿ noncompliance, and three of seven failures were attributed to severe swelling beyond the length of the microneedle or no available dorsal vein for an indwelling needle.These patients were excluded from this study.Fifty (42.37%) patients with ivcs received stent implantation.The overall patency rate was 83.51% (81/97) during follow-up.Three patients had restenosis of the stent and secondary thrombosis 2 days after discharge, and these patients were treated with cdt and covered stents.Eight patients had dvt recurrence as a result of being out of inr therapeutic range or inadequate anticoagulation time; three of these patients had cancer (two lung cancer patients, one prostate cancer patient), and two patients had protein c and protein s deficiency.Femoral and popliteal venous insufficiency was observed in 21.65% and 30.93% of patients, respectively.Postthrombotic syndrome (pts) was found in 21.65% (21/97) of patients during follow-up; varicose veins were present in 13 patients, pigmentations were present in 8 patients, and 1 patient had a skin ulcer around the affected ankle.A total of 12 bleeding events occurred during thrombolysis; three patients had major bleeding and the others had minor bleeding.One major bleeding event was a retroperitoneal hematoma occurring the second day after filter removal.Two major bleeding events were massive gastrointestinal bleeding due to peptic ulcer.Nine minor bleeding complications were puncture site bleed ing in six patients, hematuria in two patients, and gingival bleeding in one patient.One case was related to puncture site infection, and two cases had catheter-related infections; these infections were cured by antibiotic therapy and removal of the catheters.A total of two patients suffered accidental anterior tibial artery injury, but the patients were confirmed to be without pseudoaneurysm after surgery and before discharge.There was no case of nerve injury, symptomatic pe, cerebral hemorrhage, or death related to c dt treatment.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8420141
• MDR Text Key: 138775255
• Report Number: 9612164-2019-00880
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173515
• 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
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• 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: 03/12/2019
• 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: 55 YR