UNKNOWN TRAPEASE 466P306X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-30 for UNKNOWN TRAPEASE 466P306X manufactured by Cordis Corporation.

Event Text Entries

[188514697] It was reported that a patient underwent placement of a trapease vena cava filter. The information provided indicated that the filter caused fracture, perforation, tilting and perforation into an adjacent organ. The indication for the filter placement and medical history has not been provided. 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 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 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. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity. It was reported that there was perforation of the ivc and into adjacent organ; 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 and long-term complications related it ivc filters. Without procedural films or images for review the reported event(s) could not be confirmed or further clarified. 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.
Patient Sequence No: 1, Text Type: N, H10


[188514698] As reported in the legal brief, a patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture, perforation, tilting and perforation into an adjacent organ.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1016427-2020-03973
MDR Report Key9900370
Report SourceOTHER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-30
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 ContactMRS. KARLA CASTRO
Manufacturer Street14201 NW 60TH AVE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863138372
Manufacturer G1CORDIS CORPORATION
Manufacturer Street14201 NW 60TH AVENUE
Manufacturer CityMIAMI 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 Received2020-03-30
Catalog Number466P306X
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCORDIS CORPORATION
Manufacturer Address14201 NW 60TH AVENUE MIAMI LAKES FL 33014 US 33014


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.