FDA.reportPublic FDA data

MAUDE MDR 9883234

MDR report key
9883234
Report number
1016427-2020-03964
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-26
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
MRS. 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
1466FXXXXFILTER, INTRAVASCULAR, CARDIOVASCULARCORDIS CORPORATIONDTK466FXXXX466FXXXXUNKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2601. L

Event Narratives#

N

Patient 1

AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE INDICATION FOR FILTER PLACEMENT IS NOT AVAILABLE. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, FRACTURE AND OCCLUSION. THE FILTER REMAINS IMPLANTED; THUS, UNAVAILABLE FOR ANALYSIS. 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 OPTEASE 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. 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. BLOOD CLOTS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT(S) COULD NOT BE CONFIRMED. 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.

D

Patient 1

AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, FRACTURE AND OCCLUSION.