MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); Thrombus (2101); Anxiety (2328)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The expiration date is february 2008.

Event Description

As reported by the legal department, the patient underwent placement of a trapease permanent vena cava filter.Additional information received per the medical records indicate that the patient has a history of morbid obesity, type 2 diabetes mellitus and pulmonary embolism.The patient is considered resistant to coumadin.The filter was deployed below the level of the renal veins.According to the patient profile form (ppf) the device was unable to be retrieved.The filter was in place more than 90 days, it is too risky to attempt retrieval and future perforation and fracture are likely.The patient experienced blood clots and or occlusion of the inferior vena cava.The patient continues to experience anxiety and panic.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of morbid obesity, type 2 diabetes mellitus and pulmonary embolism.The patient is considered resistant to coumadin.The filter was deployed below the level of the renal veins.According to the patient profile form (ppf) the device was unable to be retrieved.The filter was in place more than 90 days, it is too risky to attempt retrieval and future perforation and fracture are likely.The patient experienced blood clots and or occlusion of the inferior vena cava.The patient continues to experience anxiety and panic.It was reported that a patient underwent placement of a trapease vena cava filter.The information received indicated that the filter was unable to be retrieved, although there are no documented attempts at retrieval of the device, in addition that patient experienced blood clots and or occlusion of the inferior vena cava (ivc).The patient is also reported to have experienced anxiety and panic.The indication for the filter implant was pulmonary embolism (pe).The patient¿s medical history is significant for morbid obesity and type ii diabetes.The patient was also noted to be resistant to coumadin, after receiving high does, the patient was not able to reach a therapeutic international normalized ratio.The filter was placed via the right femoral vein and deployed below the level of the renal veins.There is currently no additional information available.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 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 films of the index procedure or post implant imaging, the reported retrieval difficulty, could not be confirmed and could not be further clarified at this time.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.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety does 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.

• Brand Name: UNKNOWN TRAPEASE FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 7430030
• MDR Text Key: 105442251
• Report Number: 1016427-2018-01374
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: R0305015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDE WIRE; UNKNOWN CATHETER; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Other
• Patient Age: 52 YR