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

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Embolus (1830); Occlusion (1984); Respiratory Distress (2045); Thrombosis (2100)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of trapease vena cava filter on or about (b)(6) 2004.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, the trapease filter extending into the right common iliac vein, recurrent deep vein thrombosis (dvt), and respiratory distress.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, 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 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.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Blood clots and thrombosis within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without a chest x ray available for review, the cause of the respiratory distress experienced is unable to be clarified.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) 2004.

Event Description

As reported by the legal brief, the patient underwent placement of defendants¿ trapease vena cava filter on or about (b)(6) 2004 in (b)(6).The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, the trapease filter extending into the right common iliac vein, recurrent deep vein thrombosis (dvt), and respiratory distress.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, pain and suffering, and other damages.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) and medical records indicate the filter was implanted due to left frontal lobe brain tumor and deep venous thrombosis.The patient was reported to have tolerated the index procedure well.Additionally, the patient is reported to have experienced occlusion of the inferior vena cava, pain, and continues to experience anxiety related to the device.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, the filter extending into the right common iliac vein, recurrent deep vein thrombosis (dvt), and respiratory distress.Additional information received on the patient profile form (ppf) indicated that the filter was implanted due to left frontal lobe brain tumor and deep venous thrombosis and the patient is reported to have experienced occlusion of the inferior vena cava (ivc), pain, and anxiety related to the device.The indication for the device implant was dvt in a patient with a left frontal lobe brain tumor requiring neurosurgery.The filter was implanted via the right brachial vein and deployed in the ivc with the top of the filter at the level of l3.A vena gram performed during the procedure showed a normal size ivc.The patient was reported to have tolerated the index procedure well.There is currently no additional information available.The product was not returned for analysis and the sterile lot number provided is invalid; 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.Following implant, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in extremity edema.Without the procedural films or post implant images available for review the reported, migration and blood clots and occlusion of the ivc could not be confirmed or further clarified.The timing and mechanism of the events could not be verified, nor could an exact cause be determined.Additionally, without post implant films for review the report of clotting, occlusion, blood clots and migration could not be confirmed, or a cause be determined.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without the patient¿s medical history and the limited information provided it is not possible to discern what factors may be contributing to the patient¿s respiratory distress.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• MDR Report Key: 6663334
• MDR Text Key: 78283347
• Report Number: 1016427-2017-00394
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR