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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306AU
Device Problem Failure to Align (2522)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Erosion (1750); Cellulitis (1768); Edema (1820); Embolus (1830); Occlusion (1984); Swelling (2091); Perforation of Vessels (2135)
Event Date 11/28/2011
Event Type  Injury  
Manufacturer Narrative

Occupation: other, senior counsel, litigation. Five years and seven months after the index procedure, the patient presented to the er for severe right foot pain and foot swelling. The patient had a recent admission for acute kidney injury on chronic kidney disease and hyperkalemia and found to have a right distal posterior lower extremity ulcer with wound infection with (b)(6). The patient was discharged three days later, discharge diagnosis was acute gout flare up, anterior cruciate ligament tear, lateral meniscus tear and chondromalacia lateral compartment. A ct scan of the foot was performed and noted soft tissue edema, no drainable collections were identified. Seven years after the index procedure, the patient underwent a computed tomography scan. The images were submitted for outside review eight years after the index procedure. The findings from the reviewer noted that the trapease filter is positioned below the level of the renal veins, the filter is tilted, and is likely embedded in the posterior wall at the caval bifurcation. Five of six filter struts perforate the caval wall, the lateral and posterolateral perforating struts impinge directly on the anterior surface of the right psoas muscle. Please note that this is the initial report for this product. Additional information is pending and will be submitted within 30 days of receipt.

 
Event Description

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 tilt of the filter, embedment of the filter in the posterior wall and anterior caval wall, perforation of the caval wall from fiver filter struts, and lateral and posterolateral struts are impinged directly into the anterior surface of the right psoas muscle. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. According to the patient profile form the patient indicated that the filter perforated outside the wall of the inferior vena cava (ivc), tilted, was embedded and unable to be retrieved. The patient became aware of the events approximately eight years after the index procedure. There has been no attempt to retrieve the filter. The patient also reports back and leg pain, and legs are swollen all the time. In addition to mental anguish related to the filter. The patient¿s history on admission is noted to be cerebrovascular accident (cva) with no significant deficit, deep vein thrombosis (dvt), acute chronic kidney disease, knee sprain, transient ischemic attack (tia), hyperlipidemia, accelerated hypertension, (b)(6) and morbid obesity. A week before the patient was admitted to the emergency room after experiencing right side weakness. The patient was noted to have had an intraparenchymal hematoma of the left basal ganglia. The patient underwent placement of the trapease vena cava filter for deep vein thrombosis in the right lower extremity. The filter was placed via the right common femoral vein and deployed at the level of l3. The patient tolerated the procedure well. One day after the index procedure the patient underwent a computed tomography (ct) scan of the abdomen. The impression notes of the ct scan noted that two ivc filters were present. Nine days after the filter implant, the patient had complaints of pain and weakness in the right foot. A ct scan of the head noted a resolved bleed in the left basal ganglia area with mild surrounding edema. An infusion thrombolysis was attempted due to acute onset of right lower extremity pain and swelling. An ivc and right lower extremity venogram was performed and showed a significant amount of clot throughout the right lower extremity extending into the ivc filter. The patient underwent a ultra sound of the right lower extremity for pain and edema. Results of the scan noted occlusive thrombus throughout the deep venous system growing into the deep veins of the calf. A mechanical thrombectomy was performed, post thrombectomy showed no significant change and close inspection showed clot extending above the level of the filter, placing the patient at risk for pulmonary embolism (pe). As such an additional ivc filter was placed above the trapease filter. Eleven days after the index procedure, the patient had a retroperitoneal ultrasound for flank pain, results noted mild to moderate left kidney hydronephrosis. An abdominal x-ray was performed for complaints of abdominal pain. Results showed no acute process and two ivc filters were present. Sixteen days after the index procedure, the patient underwent an ultrasound of the left lower extremity, due to edema. Results of the exam noted extensive occlusive thrombus throughout the deep venous system of the left lower extremity from the common femoral vein through the popliteal vein.

 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9674217
MDR Text Key187271195
Report Number1016427-2020-03795
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2014
Device MODEL Number466P306AU
Device Catalogue Number466P306AU
Device LOT Number15449276
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/05/2020 Patient Sequence Number: 1
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