MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Thrombosis (2100)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, filter thrombosis post implant, pulmonary embolism (pe), and shortness of breath.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.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.Blood clots, pe and thrombosis within the filter do not represent a device malfunction.Shortness of breath does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, filter thrombosis post implant, pulmonary embolism, and shortness of breath.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Additional information was received from the patient profile form (ppf) that there were blood clots, clotting/occlusion of the of the inferior vena cava (ivc).The device is unable to be retrieved.¿the filter is in place for more than 90 days, too risky to attempt retrieval.Future perforation and fracture are likely.¿ an unsuccessful percutaneous removal attempt was made to remove the filter approximately 6 years and 8 months after it was implanted.The patient further reported there was extensive clotting in the lungs, trouble breathing and fear of possible device failure in the future.Additional information obtained from the patient¿s medical records indicate approximately 7 years after filter placement, the patient presented for filter removal.The indications for the procedure were due to pain and heavy feeling in legs with occlusion of the ivc and prominent abdominal collateral venous flow.Multiple attempts were made to pass the right iliac vein.Only collateral flow was identified.Multiple attempts were made from a left common femoral access to pass the ivc without success and access was then made from the right internal jugular vein.The left iliac vein and the inferior vena cava were ballooned then a venocavogram was performed.Thrombus was found within the trapease filter.Continuous aspiration thrombectomy was performed with a cat8 catheter and separator wire.Some thrombus was removed.Multiple attempts to hook the trapease filter were unsuccessful.At filter placement the trapease filter was deployed below the renal veins.The patient tolerated the procedure well.The indication for filter placement was not documented.Based on the additional information received, updates were made to the following (b)(4)).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Report was generated in error.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter malfunctioned and caused filter thrombosis, pulmonary embolism, and shortness of breath.In addition, the device is unable to be retrieved, there were blood clots, clotting and/or occlusion of the of the inferior vena cava (ivc).The indication for filter placement was not documented.The filter was placed via the right femoral vein and deployed below the level of the renal veins.The patient tolerated the procedure well with no immediate complications.Approximately seven years post implant an unsuccessful percutaneous attempt was made to retrieve the filter.The indication for the explant was pain and heavy feeling in legs with occlusion of the ivc and prominent abdominal collateral venous flow.The right common femoral vein was initially accessed.Multiple attempts to pass an occluded right iliac vein were unsuccessful, only collateral flow was identified.The left common femoral vein was then cannulated and multiple attempts to pass a guidewire past the inferior vena cava filter were unsuccessful.Next, the right internal jugular vein was cannulated, and a 6 fr sheath inserted.Using a 5fr catheter and a straight glidewire, the ivc filter was passed and the tip of the wire was placed into the left common and external iliac vein, the wire was snared and brought through the left groin.The iliac vein and the ivc were ballooned initially to 6 atmospheres (atm) and secondarily to 10 atms.An inferior venacavogram was performed and thrombus was identified within the filter.Continuous aspiration thrombectomy was performed with a cat8 catheter and separator wire, some thrombus was removed.Multiple attempts to hook the trapease filter were unsuccessful.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.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.Collateral circulation is established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.Shortness of breath and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.After further review of additional information received the following.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7436247
• MDR Text Key: 105673687
• Report Number: 1016427-2018-01390
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15308000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 52 YR