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

Catalog Number 466P306X

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: in-situ snare, sos omni-cook tip deflector wire.Literature citation: scher et al (2015) retrieval of trapease and optease inferior vena cava filters with extended dwell times.Journal of vascular and interventional radiology; 1-7.Complaint conclusion: as reported by scher et al, retrieval of trapease and optease inferior vena cava filters with extended dwell times; journal of vascular and interventional radiology (2015), 1-7; there were a total of 362 ivc filter retrievals between (b)(6) 2009, and (b)(6) 2015.Five of these patients had optease filters and six had trapease filters.All optease and trapease filters were placed at outside institutions.All patients included in the study had an attempted optease or trapease ivc filter removal greater than 60 days after initial placement.One patient who had a trapease filter successfully retrieved was excluded from the study because the date of filter insertion could not be obtained.In the first case involving a trapease removal, a (b)(6) female patient experienced ivc thrombosis and ivc stenosis.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.Without further testing, it is not possible to determine the exact cause of the reported events.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 and occurs in approximately 3.6 to 11.2 % of all patients¿.Ivc stenosis is also well documented in the ifu.Factors that may have influenced the event include patient, pharmacological and lesion.There is no indication that the reported events were related to a design or manufacturing issue, therefore no corrective action is needed.

Event Description

As reported by scher et al, retrieval of trapease and optease inferior vena cava filters with extended dwell times; journal of vascular and interventional radiology (2015), 1-7; there were a total of 362 ivc filter retrievals between (b)(6) 2009, and (b)(6) 2015.Five of these patients had optease filters and six had trapease filters.All optease and trapease filters were placed at outside institutions.All patients included in the study had an attempted optease or trapease ivc filter removal greater than 60 days after initial placement.One patient who had a trapease filter successfully retrieved was excluded from the study because the date of filter insertion could not be obtained.In the first case involving a trapease removal, a (b)(6) female patient experienced ivc thrombosis and ivc stenosis.

Manufacturer Narrative

Additional information received and revised event description: additional information was received and the event description updated.As reported by scher et al, retrieval of trapease and optease inferior vena cava filters with extended dwell times; journal of vascular and interventional radiology (2015), 1-7; a (b)(6) year old female patient who had a trapease filter experienced 5% inferior vena cava (ivc) stenosis at the time of filter retrieval.The reason for filter retrieval was ivc thrombosis.The filter was removed with an in-situ snare/sos omni-cook tip deflector wire.The filter dwell time was 280 days.The purpose of this review was to demonstrate that optease and trapease filters can be removed after dwell times greater than 60- days.A retrospective review was performed of patients who underwent an attempted removal of a trapease or optease filter with a greater than 60 days dwell time between 2009 and 2015 at a single institution.Eleven patients within this time span were identified and 10 were included in the review.One patient was excluded from the study because the date of filter placement was unknown.All filters were successfully retrieved.Retrieval of filters followed the same general procedure, although the steps different slightly in each case.Techniques varied, as the procedures were spread among four operators.Three cases were performed under conscious sedation.The remaining seven cases were performed with an anesthesiologist to provide deep sedation (two patients) or general anesthesia (five patients).Anticoagulants were discontinued before treatment, and patients underwent heparinization during the procedure.Following filter retrieval, all patients initiated or resumed an anticoagulation regimen.If performed in conjunction with treatment of caval thrombosis, retrieval was attempted following restoration of flow within the ivc at the discretion of the operator.Venography was performed to evaluate vessel patency and filter orientation.The filter was engaged at the cranial and caudal apices.The apices were captured by creating in-situ snares or using rigid endobronchial forceps.In situ snares were performed by passing a wire under the filter apex, snaring the distal end, and pulling the wire through the sheath.If an in situ snare could not be created, endobronchial forceps were used to capture one or both apices.When each apex had been secured, the jugular and femoral sheaths were advanced towards each other, collapsing the filter.This motion had to be repeated multiple times to free the filter from the hyperplastic neointimal tissue surrounding it.If the filter could not be freed, clamshell forceps were inserted in tandem with an in situ snare or endobronchial forceps and used to dissect neointimal tissue away from the filter where the struts contact the wall.This mdr report is related to report#'s: 9616099-2015-00390, 9616099-2015-00391, 9616099-2015-00387, 9616099-2015-00392, 9616099-2015-00393, 9616099-2015-00381, 9616099-2015-00394, 9616099-2015-00395, 9616099-2015-00380.The device was not returned for analysis and no sterile lot was provided, therefore no dhr review nor product analysis will be completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: as reported by scher et al, retrieval of trapease and optease inferior vena cava filters with extended dwell times; journal of vascular and interventional radiology (2015), 1-7; a (b)(6) female patient who had a trapease filter experienced 5% inferior vena cava (ivc) stenosis and retrieval difficulty at 280 days.The patient had a previous failed attempt to retrieve the filter.The reason for filter retrieval was ivc thrombosis.Anticoagulants were discontinued before treatment, and the patient underwent heparinization during the procedure.Sedation or general anesthesia was administered.The filter was removed with an in-situ snare as well as an sos omni-cook tip deflector wire.The tip deflector wire (non-cordis) within an sos omni catheter (non-cordis) was used to disrupt synechia and organized thrombus.The apices were attempted to be captured by creating in situ snares.The snare was formed by passing a wire under the filter apex, snaring the distal end and pulling the wire through the sheath.Motion to collapse the filter had to be repeated multiple times to free the filter from the hyperplastic neointimal tissue surrounding it.Following filter retrieval, anticoagulation regimen was initiated/ resumed.The patient was monitored in the recovery area for a minimum of two hours.Post procedural ivc stenosis was calculated based on measurements made from the anterior/posterior completion ivc venogram.No stenosis was noted at the 5 week follow up venography.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The reported retrieval difficulty from vessel wall could not be confirmed as the device was not returned nor were procedural films provided.The trapease filter is a permanent vena cava filter designed for percutaneous delivery.The symmetrical and self-centering trapease filter is laser cut from nickel titanium alloy (nitinol) tubing.The proximal and distal baskets of the filter are connected by six straight struts that contain a proximal and distal hook designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 and occurs in approximately 3.6 to 11.2 % of all patients¿.Factors that may have influenced the event include patient, pharmacological and lesion.Procedural factors (retrieval of a permanent trapease filter) likely contributed to the difficulty experienced by the customer in retrieving the filter.Additionally, the development of endothelialization, would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.The article also reported ivc stenosis.Stenosis is an abnormal narrowing, of the ivc in this case, which may be caused by a lesion that reduces the space of lumen (e.G., atherosclerosis).Other contributing factors include, but are not limited to, diabetes, inflammation, infection, hypertension, hyperlipidemia, and cigarette smoking.Without a sterile lot number or return of the device, there is no indication that these events are related to the design and manufacturing process of the device; therefore, no corrective action 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: 5018659
• MDR Text Key: 23654942
• Report Number: 9616099-2015-00382
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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
• Date Manufacturer Received: 09/23/2015
• 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 Age: 49 YR