MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).The patient presented in the emergency room with massive swelling of both lower limbs worsening over 72 hours and an ill defined dull lower back pain for 4 weeks.Peripheral venous doppler showed echogenic thrombus involving both iliac veins and extending into the inferior vena cava with patent bilateral femoral, popliteal and deep calf veins.Past history of recurrent pulmonary embolism and placement of non-retrievable permanent inferior vena-caval filter (trapease permanent vena cava filter by cordis) approximately 6 months ago at a district hospital.Previous records revealed right segmental and sub-segmental pulmonary thrombo-embolism.And protein c deficiency.Ct venography of the lower limbs and abdomen revealed ivc filter in situ with occlusive thrombus involving both iliac veins extending into inferior vena cava up to the cranial extent of the filter.Patient was taken up for intravenous catheter directed thrombolysis (cdt) as he presented within the window period for thrombolysis.In angio suite, patient was placed in supine position and both common femoral veins were accessed using 16-gauge needle under us guidance.Vascular sheaths (7-f) were placed bilaterally.Initial venography via bilateral sheaths revealed non-opacification of bilateral iliac veins and ivc up to cranial end of filter with reformation of supra renal ivc via collaterals,suggestive of occlusive thrombus in the iliac veins and infrarenal ivc (fig 1).Using usual guidewire catheter combination, the thrombus and ivc filter struts were negotiated.Patency of the suprarenal ivc was confirmed.Cdt was initiated via two 5-f multiple-side-hole infusion catheters, 30-cm-long (craigg-mcnamara valved infusion catheter, ev3) positioned at desired level via bilateral femoral access.The catheter was positioned such that the 30 cm infusion length extended through the entire length of thrombus covering common iliac veins up to the cranial extent of the vena cava filter.A total of 5mg of bolus of r-tissue plasminogen activator 103 was administered followed by an infusion at a rate of 1mg/hr via each catheter.Continuous monitoring in the recovery room for possible complications of thrombolytic therapy was performed.After initiation of cdt check venogram were performed at an interval of 12, 24, and 36 hours.During each check venogram, mechanical aspiration of thrombus was attempted using a 7f 108 guiding catheter along with clot maceration using balloon catheter.Venogram performed at 36 109 hours post initiation of cdt, showed satisfactory clearance of thrombus from bilateral iliac veins and ivc except for a residual focal filling defect and mild hold up of contrast within ivc at the level of filter which could not be lysed likely due to the chronic nature of the thrombus.(fig 2) the age of the patient without a valid indication for a long term need of ivc filter guider our decision to recanalise the filter segment of ivc to exclude the residual thrombus nidus from circulation.The source images as well as vrt 3d reconstruction images (volume rendered technique) obtained from pre-procedure ct venography helped us to study the design of the 116 ivc filter and help to plan alignment of the stents.The maximum diameter of ivc was 20mm on antero-posterior and lateral projection.Vrt image revealed the maximum diameter of petal as 3.2mm and the craniocaudal length of filter up to barbsas 36mm.As per our planning on ct images, by manipulating catheter & angled 0.035 glidewire (terumo) wire combination, we were able to cannulate two opposite petals (confirmed on different projections with the help of dynact (at 3 0 clock and 9 0 clock position on axial ct images).Meticulous care was taken to prevent the two guidewires from crossing between the filter and ivc or criss crossing through a non-targeted petal.After ensuring the position of guidewires and straight parallel passage through the corresponding cranial petal lumen, two balloon mounted stents {10mm x 59 mm herculink, biotronik &10mm x 57 mm omnilink elite abbott )both the stents were aligned and deployed across the filter in a double barrel alignment.Completion venogram showed brisk flow with no further hold up of contrast through the recanalized ivc filter.The filter was left undisturbed except for creating two parallel channels within it and exclusion of the possible nidus for future thrombosis.(fig 5) he was discharged the next day on oral anticoagulants(warfarin) bridged with low molecular weight heparin with a target inr between 2.5.Post procedure follow up doppler study and ct venography were performed.The native ivc, 133 parallel stents within ivc and bilateral iliac veins were widely patent without evidence of 134 residual or recurrent thrombus.(fig 6).This article was found during a recent clinical evaluation review/literature search of this device.The citation is as follows : banerjee et al, double barrel in situ recanalization of thrombosed non retrievable ivc filter, annals of vascular surgery (2016).

Event Description

As noted in the publication by banerjee et al, double barrel in situ recanalization of thrombosed non retrievable ivc filter, annals of vascular surgery (2016); we report a case of endovascular recanalization of complete thrombotic occlusion of the inferior vena cava (ivc) and bilateral iliac veins utilizing the architectural knowledge of the in-situ permanent ivc filter in a (b)(6) male.The infra-renal permanent ivc filter was trapease permanent vena cava filter (cordis)placed at an outstation hospital for pulmonary embolism.Being permanent variant of filter, percutaneous removal was not possible.The patient had severe venous claudication and an attempt to recanalize the blocked filter was considered, in view of the age no justifiable indication for a long term filter.Following pharmaco-mechanical catheter directed thrombolysis , there was residual focal flow limiting thrombus within the filter.The design of the trapease cordis filter was instrumental in our decision to attempt to recanalize the filter in situ using two parallel stents with the filter struts as anchoring pillars in a double barrel alignment.In similar cases of persistent trapease filter related thrombotic occlusion of the ivc, this double barrel in situ recanalization shall be a viable alternative to the well described technique of crushing the filter and recanalizing it with a single stent.

Manufacturer Narrative

As noted in the publication by banerjee et al, double barrel in situ recanalization of thrombosed non retrievable ivc filter, annals of vascular surgery (2016); we report a case of endovascular recanalization of complete thrombotic occlusion of the inferior vena cava (ivc) and bilateral iliac veins utilizing the architectural knowledge of the in-situ permanent ivc filter in a (b)(6) male.The infra-renal permanent ivc filter was trapease permanent vena cava filter (cordis)placed at an outstation hospital for pulmonary embolism.Being permanent variant of filter, percutaneous removal was not possible.The patient had severe venous claudication and an attempt to recannalize the blocked filter was considered, in view of the age no justifiable indication for a long term filter.Following pharmaco-mechanical catheter directed thrombolysis , there was residual focal flow limiting thrombus within the filter.The design of the trapease cordis filter was instrumental in our decision to attempt to recannalize the filter in situ using two parallel stents with the filter struts as anchoring pillars in a double barrel alignment.In similar cases of persistent trapease filter related thrombotic occlusion of the ivc, this double barrel in situ recanalization shall be a viable alternative to the well described technique of crushing the filter and recannalizing it with a single stent.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication listed in the ifu as such and occurs in approximately 3.6 to 11.2 % of all patients¿.Factors that may have influenced the event include patient, pharmacological and lesion.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5532756
• MDR Text Key: 41383954
• Report Number: 9616099-2016-00153
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

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
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 23 YR