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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problem Complete Blockage (1094)
Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Edema (1820); Occlusion (1984); Thrombosis (2100)
Event Date 09/10/2017
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal team, the patient underwent placement of trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: post-implant dvt/pe. As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages and required extensive medical care and treatment. As a further proximate result. Patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The following additional information was received per the patient¿s implant records: the filter was implanted at the level of the superior endplate of the l2 vertebral body due to dvt. The patient tolerated the procedure well. Per the patients¿ medical records, the patient¿s medical history included dvt, pancreatitis, neuropathy, gastritis, djd, bipolar disorder, back pain, and arthritis. Approximately four years post implantation, the patient presented with bilateral lower extremity swelling. The patient said that he had developed swelling with pain on the right leg greater than left. A venogram was performed which showed some clot in the ivc filter. The venogram demonstrated that there was clot all the way from the femoral vein and the physician believed it went up to the common femoral vein, external, and common iliacs all the way up to the ivc; there was clot in the ivc and there was subacute clot in the ivc and the rest of it in the common and external iliacs were acute. The patient had tpa infusion overnight and presented for repeat imaging the next day. The patient reported improvement of his edema but persistent pain in his legs bilaterally. There was extensive thrombus present in the lower extremity veins bilaterally and ivc. The popliteal and femoral vein appeared better, but the iliac veins and ivc appeared worse. Imaging performed from the ivc (through the filter) into the r popliteal vein showed the ivc filter was occluded and worse than the day before. There was extensive clot present with occasional open lumen visualized. The patient was referred for potential angiovac therapy. During the same hospitalization, the patient experienced chest pain. Coronary artery calcification was present. There was bullous emphysema. According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc. The patient also reports suffering from anxiety.
 
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Brand Name466P306X
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 Key8233241
MDR Text Key132596440
Report Number1016427-2019-02384
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466P306X
Device Catalogue Number466P306X
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 Received01/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/10/2019 Patient Sequence Number: 1
Treatment
6F ANGIOGRAPHIC CATHETER; SHEATH
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