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 Problems Thrombosis (2100); Stenosis (2263)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Please note the attached literature article.Concomitant products: in-situ snare.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 was 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 second case involving trapease removal, a (b)(6) female patient experienced ivc thrombosis and ivc stenosis.This patient underwent an angioplasty and stent placement at the time of retrieval.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 source of this event.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.Ivc stenosis in the filter does not represent a device malfunction.Ivc stenosis is a well known and forseeable event listed in the ifu.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.There is no indication that the event was 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 was 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 second case involving trapease removal, a (b)(6) female patient experienced ivc thrombosis and ivc stenosis.This patient underwent an angioplasty and stent placement at the time of retrieval.

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; at the time of retrieval at 129 days, a (b)(6) female patient who had a trapease filter had inferior vena cava (ivc) stenosis of 55%.Retrieval difficulty from the vessel wall was experienced.The author also reported there was ivc thrombosis and the patient experienced intermittent leg swelling.The filter was being removed due to the thrombus.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.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.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.Completion venography was performed to evaluate the ivc for any potential injury.This patient underwent an angioplasty and stent placement at the time of retrieval.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 and no ivc stenosis was noted upon follow up.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 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.Additionally the author reported stenosis of the inferior vena cava (ivc).Stenosis is an abnormal narrowing, of the ivc in this case, which may be caused by a lesion that reduces the space of the lumen (e.G., atherosclerosis).Other contributing factors include, but are not limited to, diabetes, inflammation, infection, hypertension, hyperlipidemia, and cigarette smoking.The noted stenosis may have contributed to decreased venous return and leading to the leg swelling experienced by the patient.The reported retrieval difficulty form the vessel wall and filter fracture could not be confirmed as the device was not returned for analysis nor were procedural films provided.The instructions for use (ifu) notes that trapease permanent vena cava filter is designed for percutaneous delivery of a permanent vena cava filter to the inferior vena cava (ivc).The baskets are connected by six straight struts that contain a proximal and distal hook designed for fixation of the trapease filter to the vessel wall.Upon deployment, the filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability.Attempts to retrieve the permanent filter, along with the likely presence of endothelialization at 129 days, likely contributed to the difficulty experienced by the customer.Without a sterile lot number or return of the device, there is no indication that these events are related to the manufacturing process of the device; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

The device will not be returned for analysis and no sterile lot was provided, therefore no dhr review nor product analysis will be conducted.Additional information will be submitted within 30 days of receipt.This regulatory report is related to mdr report#s: 9616099-2015-00390, 9616099-2015-00391, 9616099-2015-00387, 9616099-2015-00392, 9616099-2015-00393, 9616099-2015-00382, 9616099-2015-00394, 9616099-2015-00395, 9616099-2015-00380.Addendum (08/20/2015): event description revised based on additional information received: 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 removed had inferior vena cava (ivc) stenosis of 55% at the time of retrieval.The reason for retrieval was ivc thrombosis.This patient underwent an angioplasty and stent placement at the time of retrieval.The dwell time of the filter was 129 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.

• 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: 5014207
• MDR Text Key: 23435439
• Report Number: 9616099-2015-00381
• 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

• 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: Not provided
• Initial Date FDA Received: 08/19/2015
• 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: 61 YR