UNKNOWN TRAPEASE 466P306X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-31 for UNKNOWN TRAPEASE 466P306X manufactured by Cordis Corporation.

Event Text Entries

[188517521] Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. 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 perforation and tilting of the filter. The indication for the filter implant has not been provided and there is currently no additional information available for review. 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 ivc 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity. 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 and long-term complications related to ivc filters. The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event. It is unknown if the tilt contributed to the reported perforation. Without procedural films or post implant imaging available for review, the reported filter tilt and perforation could not be confirmed or further clarified. There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly. Please note that this is the initial/final report for this product.
Patient Sequence No: 1, Text Type: N, H10


[188517522] As reported by the legal brief, the patient underwent placement of a trapease vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and tilting of the filter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1016427-2020-03978
MDR Report Key9908047
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARLA CASTRO
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863138372
Manufacturer G1CORDIS CORPORATION
Manufacturer Street14201 NW 60 AVENUE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal Code33014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TRAPEASE
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Product CodeDTK
Date Received2020-03-31
Catalog Number466P306X
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CORPORATION
Manufacturer Address14201 NW 60 AVENUE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-31

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