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

Catalog Number 466P306X

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

Patient Problem Stenosis (2263)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: in-situ snare, endobronchial forceps, heparin.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.The device will not be 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.

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; the (b)(6) male patient with a trapease filter had 40% inferior vena caval stenosis at the 10 week follow-up venography.An in-situ snare/endobronchial forceps were used to retrieve the filter.The reason for filter retrieval was "no longer indicated." the filter dwell time was 3,282 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.

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; in a 57 year old patient, retrieval difficulty of the trapease filter from the vessel wall was experienced; attempts to collapse the filler was repeated multiple times.There was 40% ivc stenosis at the time of retrieval at 3282 days.The filter was being removed as it was ¿no longer indicated¿.Anticoagulants were discontinued before treatment, and the patient underwent heparinization during the procedure.Sedation or general anesthesia was administered.The filter was engaged at the cranial and caudal apices.An in-situ snare in addition to endobronchial forceps were used to remove the filter.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.An endobronchial forcep was used to capture one end due to the inability to create an in situ snare.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.Following filter retrieval, anticoagulation regimen was initiated/ resumed.After the filter was removed, completion venography was performed to evaluate the ivc for any potential injury.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 and 40% ivc stenosis was noted at the 10 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.Procedural factors (retrieval of a permanent trapease filter) likely contributed to the difficulty experienced by the customer.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.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, 9616099-2015-00382, 9616099-2015-00394, 9616099-2015-00395, 9616099-2015-00380.

• 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: 5038457
• MDR Text Key: 24445371
• Report Number: 9616099-2015-00391
• 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: 08/28/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR