MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135)

Event Date 05/12/2017

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 parent vs.Cordis, an unspecified period after a trapease vena cava filter was implanted, the filter reportedly malfunctioned, perforated the ivc wall causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required 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.Perforation, clots, blood clots and occlusion do not represent a device malfunction.The reported events 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 parent vs.Cordis, an unspecified period after a trapease vena cava filter was implanted, the filter reportedly malfunctioned, perforated the ivc wall causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.

Manufacturer Narrative

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

Manufacturer Narrative

As reported, the patient underwent placement of an trapease inferior vena cava (ivc) filter on or about (b)(6) 2012.Per the patient profile form (ppf), the device was implanted due to pulmonary embolism, ulcerative colitis, acute anemia, lower gi bleeding.The patient was reported to have tolerated the procedure well.The filter subsequently malfunctioned, perforated the ivc wall and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.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.It was also reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6609188
• MDR Text Key: 76592186
• Report Number: 1016427-2017-00327
• 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
• Report Date: 02/27/2018

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 Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 15582192
• Device Lot Number: 15582192
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2017
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 01/18/2018; 02/19/2018
• Supplement Dates FDA Received: 02/16/2018; 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR