FDA.reportPublic FDA data

MAUDE MDR 9905665

MDR report key
9905665
Report number
1016427-2020-03976
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARLA CASTRO
Address
14201 NW 60TH AVE MIAMI LAKES FL 33014 US
Phone
786-786-7863
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN TRAPEASEFILTER, INTRAVASCULAR, CARDIOVASCULARCORDIS CORPORATIONDTK466P306XUNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. L

Event Narratives#

N

Patient 1

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 AND OCCLUSION. THE INDICATION FOR THE FILTER IMPLANT, PATIENT MEDICAL HISTORY AND PROCEDURAL DETAILS HAVE 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 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. OCCLUSION WAS REPORTED, HOWEVER WITH THE LIMITED INFORMATION PROVIDED THE EVENT COULD NOT BE FURTHER CLARIFIED, IT IS UNKNOWN IF IT WAS A STENOTIC OR THROMBOTIC EVENT. BLOOD CLOTS, CLOTTING AND/OR OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND/OR THE VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE EVENTS AND THE DEVICE. THERE IS NOTHING IN THE INFORMATION PROVIDED TO SUGGEST THAT THERE IS 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. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

D

Patient 1

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 OCCLUSION THAT CAUSES INJURY AND DAMAGE TO THE PATIENT.