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

Model Number 466P306X

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received, it will be provided.The exact implantation date is unknown.Complaint conclusion: as reported by the legal department, the plaintiff 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, post-implant pulmonary embolism and deep vein thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, 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 inferior 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 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.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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.

Event Description

As reported by the legal department, the plaintiff 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, post-implant pulmonary embolism and deep vein thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.

Manufacturer Narrative

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, post-implant pulmonary embolism and deep vein thrombosis.The following additional information received per the patient profile form (ppf) indicates the patient is reported to have experienced clotting, occlusion of the inferior vena cava, leg pain, leg swelling, filter is unable to be retrieved although there have been no known recorded retrieval attempts, and the patient is reported to continue to experience anxiety related to the device.The patient became aware of these issues approximately five years after the implant.The patient¿s medical history and the indication for the device implant has not been provided.According to the medical records the device was placed without complication.There is currently no additional information available.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 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 (b)(6) 2008; 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 post procedural pulmonary embolism do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.With the limited information provided it is not possible to determine what factors may have contributed to the reported issues; however, the report of the device being embedded may be related to the body¿s natural tendency to endothelialize a foreign object, although without procedural films or post implant imaging it is not possible to determine what factors may have contributed to the reported 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, specifically but not limited to the initial diagnosis and indication for the device implant.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety, leg pain and swelling 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.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, post-implant pulmonary embolism and deep vein thrombosis.The patient is also reported to have experienced clotting, occlusion of the inferior vena cava (ivc), leg pain and swelling and the filter is unable to be retrieved.There have been no documented attempts to retrieve the filter.Additional information also reported that the ivc filter is occluded and the patient has post phlebitic syndrome.The patient became aware of these issues approximately five years after the implant.The patient¿s medical history and the indication for the device implant has not been provided.According to the medical records the device was placed without complication.There is currently no additional information available.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 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 (b)(6) 2008; 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 post procedural pulmonary embolism do not indicate a device malfunction.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported 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, specifically but not limited to the initial diagnosis and indication for the device implant.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety, leg pain and swelling 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.

Event Description

As reported in 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, post-implant pulmonary embolism and deep vein thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.The following additional information received per the patient profile form (ppf) indicates the patient is reported to have experienced clotting, occlusion of the inferior vena cava, leg pain, leg swelling, filter is unable to be retrieved although there have been no known recorded retrieval attempts, and the patient is reported to continue to experience anxiety related to the device.According to the information received in the patient profile short form, the patient reported occluded ivc filter, deep vein thrombosis, and post phlebitic syndrome.

Manufacturer Narrative

Investigation summary: patient code (b)(4) was used as there is no code available for 'phlebitic syndrome'.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; cashir road; tipperary ; EI
• MDR Report Key: 6845688
• MDR Text Key: 85004627
• Report Number: 1016427-2017-00581
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2018

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 Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2017
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 01/19/2018; 06/08/2018; 07/10/2018
• Supplement Dates FDA Received: 02/15/2018; 07/06/2018; 07/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR