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

Catalog Number 466P306X

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) requiring stent placement.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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not 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 and occlusion within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).The instructions for use (ifu) note vessel injuries and recurrent pulmonary embolism as possible long-term complications associated with filter implantation.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.  implant date: on or about (b)(6) 2006.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) requiring stent placement.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

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) requiring stent placement.The filter is reported to be occluded, embedded and unable to be retrieved, however; there have been no documented attempts made to remove the filter.The patient became aware of the reported events nine years and three months post implantation.The patient also reports to be suffering from mental anguish, embarrassment and shamefulness of the body as it has veins all over.The patient is reported to have a history of morbid obesity, the indication for the filter placement was not provided.The device was implanted via the right internal jugular vein and deployed with the tip at the level of the l2 vertebral body without any complications.The patient tolerated the index procedure well.There is currently no additional information available.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.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.The reported ¿filter embedded in wall of the ivc¿ and retrieval difficulty, could not be confirmed and could not be further clarified at this time.The reported event notes implantation of the filter on or about november 2006; however, the attempted retrieval date or an actual attempt at retrieval, is unknown at this time.Blood clots, clotting, device occlusion related to clotting and ivc stenosis do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Venous insufficiency and post-thrombotic syndrome do not represent a device malfunction and may be related to underlying patient specific issues.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety and bulging veins 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.Section: the following additional information received per the medical records indicate that the patient has a history of morbid obesity.During the implantation procedure, the filter was deployed with the tip at the level of the l2 vertebral body without any complications.The patient tolerated the index procedure well.According to the patient profile from (ppf), the patient became aware of the reported events nine years and three months post implantation.The filter is reported to be occluded, embedded and unable to be retrieved.However, there have been no attempts made to remove the filter.The patient also reports to be suffering from mental anguish, embarrassment and shamefulness of the body as it has veins all over.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6656483
• MDR Text Key: 78043872
• Report Number: 1016427-2017-00376
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 72 YR