MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an trapease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief in (b)(6) vs.Cordis, an unspecified period of time after the patient underwent placement of defendants¿ trapease vena cava filter the filter reportedly subsequently malfunctioned causing injury and damages to the patient including, but not limited to, extensive dvt, blood clots, clotting and occlusion of ivc, clotting of the extremities, and (required) thrombolysis.As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.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.  the events reported do not represent a device malfunction.The reported dvt, blood clots, clotting and occlusion of ivc, clotting of the extremities could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.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 in the legal brief in (b)(6) vs.Cordis, an unspecified period of time after the patient underwent placement of defendants¿ trapease vena cava filter the  filter reportedly subsequently malfunctioned causing injury and damages to the patient including, but not limited to, extensive dvt, blood clots, clothing and occlusion of ivc, clotting of the extremities, and (required) thrombolysis.As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

Please note that the device component code is corrected from (b)(4) which was indicated in the initial report in error, to (b)(4), (filter), the device associated with the reported event.

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 pulmonary embolism and respiratory failure.The patient was reported to have tolerated the index procedure well.The patient is reported to have experienced swelling, pain, and has had to undergo thrombolysis to clear clots from his veins.The patient is reported to continue to experience anxiety related to the device.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter on or about (b)(6) 2008.Per the patient profile form (ppf), the filter was implanted due to pulmonary embolism and respiratory failure.The patient was reported to have tolerated the index procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, extensive dvt, blood clots, clotting and occlusion of ivc, clotting of the extremities, and thrombolysis.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 patient is reported to have experienced swelling, pain, and has had to undergo thrombolysis to clear clots from his veins.The patient is reported to continue to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 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 occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pain and swelling do not represent device malfunctions and may be related to underlying patient issues.Anxiety 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6590770
• MDR Text Key: 75964649
• Report Number: 1016427-2017-00305
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1007091
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2017
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18 GAUGE NEEDLE; UNKNOWN CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR