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 (b)(6) 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 (b)(6) 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

The following additional information received per the patient profile form (ppf) indicates the patient is reported to have experienced pain on the left side of the body and is reported to continue to experience anxiety related to the device.It was reported that a patient underwent placement of a trapease vena cava filter.The information received indicated that 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.The patient became aware of these issues approximately eleven years after the device was implanted.The patient is also reported to be experiencing pain on the left side of the body and anxiety related to the device.The patient¿s medical history, indication for the device implant and procedural details have not been provided.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The timing and mechanism of the perforation has not been reported at this time and 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.Without the procedural films or post-placement imaging and the limited information provided, the report perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported event and the filter be drawn.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 this period of time, 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.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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Additionally, without post implant films for review the report of clotting, occlusion, and blood clots could not confirmed or a cause be determined.Unilateral body pain and anxiety 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.Additional information is pending and will be submitted within 30 days of receipt.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6609412
• MDR Text Key: 76589463
• Report Number: 1016427-2017-00328
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• 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: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/12/2017
• Date Manufacturer Received: 02/28/2018
• 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
• Patient Age: 59 YR