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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION JUGULAR 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION JUGULAR 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F230AJ
Device Problem Unintended Movement (3026)
Patient Problems Chest Pain (1776); Dyspnea (1816); Pain (1994); Anxiety (2328); Unspecified Tissue Injury (4559)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter. The patient is reported to have had a history of acute saddle pulmonary embolism (pe) without acute cor pulmonale. The patient presented with lower extremity deep vein thrombosis (dvt). The indication for the filter placement was reported to be as prophylaxis against recurrent pe in the setting of a contraindication to anticoagulation therapy. The filter was implanted via the right internal jugular vein and placed in an infrarenal position. The patient is reported to have tolerated the procedure well and without complications. Approximately three years and three months after the filter implantation, the patient became aware that the filter had tilted. The patient further reported having experienced shortness of breath, chest pain and anxiety associated with the filter. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the inferior vena cava (ivc) 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. Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Additionally, the timing and mechanism of the filter tilt is unknown. Due to the nature of the complaint, the reported shortness of breath and pain experienced by the patient could not be confirmed and the exact cause could not be determined. These clinical events do not represent evidence of a device malfunction. Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. The anxiety experienced by the patient does not represent a device malfunction. Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry. Given the limited information available for review, there is nothing to suggest that 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.

 
Event Description

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 filter tilting. As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages. Per the implant records, the patient was reported to have a history of acute saddle pulmonary embolism (pe) without acute cor pulmonale. Placement of the inferior vena cava (ivc) filter was advised for lower extremity deep vein thrombosis (dvt) with contraindication to anticoagulation to prevent a pe. Utilizing routine sterile technique, an ultrasound of the right internal jugular vein was performed, confirming a widely patent right internal jugular vein. Using direct ultrasound guidance, the right internal jugular vein was punctured, and a guidewire was advanced into the inferior vena cava under fluoroscopy guidance, followed by a catheter. A diagnostic vena cavogram was then performed revealing a widely patent inferior vena cava, measuring less than 3cm in diameter and demarcating the right and left renal veins. Subsequently, an optease ivc filter was successfully deployed infrarenal. The patient tolerated the procedure well; there were no complications. According to the information received in the patient profile form (ppf), the patient reports tilting of the filter, becoming aware of the event approximately three years and five months after the filter implantation, and further experienced shortness of breath, chest pain and anxiety related to the filter.

 
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Brand NameJUGULAR 55CM KIT
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key12376611
MDR Text Key268436383
Report Number1016427-2021-05345
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2019
Device MODEL Number466F230AJ
Device Catalogue Number466F230AJ
Device LOT Number17571024
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/28/2016
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: 08/27/2021 Patient Sequence Number: 1
Treatment
UNK GUIDEWIRE, UNK 5F CATHETER
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