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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.
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Manufacturer (Section D)
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8420141
MDR Text Key138775255
Report Number9612164-2019-00880
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1