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U.S. Department of Health and Human Services

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

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306AU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Calcium Deposits/Calcification (1758)
Event Date 09/01/2017
Event Type  Injury  
Manufacturer Narrative
Additional information was received from the patient profile form (ppf) that the patient states she has pain, suffering, and has fears of future additional injuries that the implant has moved or will move and cause injury or death. The patient states she had a stroke after the filter was implanted. Medical records received indicate that the patient had acute appendicitis approximately 4 ½ years after the filter was placed. The patient¿s appendix were removed and there were no procedural complications. The record also states peritoneoscopy reveals some ahesions to the anterior abdominal wall in the lower abdomen from previous surgeries. Additional medical records received indicated the patient presented to the hospital with some atypical symptoms that were tia-like with left-sided numbness approximately two months later; however, during her workup, she had a borderline abnormal ekg with some t-wave abnormality noted in inferior leads, as well as serial cardiac enzymes, all of which showed elevated troponin in the range of 0. 4-0. 5. The patient had episodes of chest pain regularly. Left heart catheterization with selective coronary angiography and left ventriculography revealed very minimal coronary artery disease and normal left ventricular function. The patient was discharged without any treatment. The patient also had a ct of the head which showed no ct evidence of an acute infarct or intracranial hemorrhage. An mri also showed no evidence of a cerebrovascular accident (cva). A venous doppler showed no evidence of bilateral lower extremity deep venous thrombosis. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
Additional information was received from a new legal filing with the patient reporting migration of the filter to the abdomen. The product remains implanted and is thus not available for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter. The indication for filter placement is not available. The device in the patient was positively identified by medical records. Approximately four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain. The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac veins showed increased amount of calcification, much greater than the expected for the patient¿s age. Per the patient profile form (ppf), the patient states she has pain, suffering, and fear and had a stroke post filter implantation. Additional medical records received indicated the patient presented to the hospital with some atypical symptoms that were tia-like with left-sided numbness; however, during her workup, she had a borderline abnormal ekg with some t-wave abnormality noted in inferior leads, as well as serial cardiac enzymes, all of which showed elevated troponin in the range of 0. 4-0. 5. The patient had episodes of chest pain regularly. Left heart catheterization revealed very minimal coronary artery disease and normal left ventricular function. The patient was discharged without any treatment. The patient also had a ct of the head which showed no ct evidence of an acute infarct or intracranial hemorrhage. An mri also showed no evidence of a cerebrovascular accident (cva). A venous doppler showed no evidence of bilateral lower extremity deep venous thrombosis. Additional information was received where the patient reported migration of the filter to the abdomen. The filter remains implanted; thus, unavailable for analysis. 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 trapease 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. Vascular calcification does not represent a device malfunction and may be related to underlying patient related issues. Stroke is a known potential adverse event associated with the use of the trapease device. Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues. 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.
 
Manufacturer Narrative
As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter. The device in the patient was positively identified by medical records. On or about four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain. The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification, much greater than the expected for the patient¿s age. As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects. As the result of the trapease filter¿s malfunction, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body. 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 event. The trapease inferior 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. Abdominal pain also does not represent a malfunction of the device. The brief also mentioned the formation of calcification. Calcification is the accumulation of calcium salts in a body tissue. It is transported through the blood stream. Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden. Calcification within a patient does not represent a device malfunction. Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter. Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event. Given the limited information available for review at this time, and the device history record (dhr) results, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.
 
Event Description
As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter. The device in the patient was positively identified by medical records. On or about four years and five months after, the patient received a scan on the abdominal region after complaints of abdominal pain. The scan revealed that the inferior vena cava (ivc) filter was in the region and both the abdomen aorta and iliac showed increased amount of calcification, much greater than the expected for the patient¿s age. As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects. As the result of the trapease filter¿s malfunction, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
juarez
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6898341
MDR Text Key251428747
Report Number9616099-2017-01466
Device Sequence Number1
Product Code DQO
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2013
Device Catalogue Number466P306AU
Device Lot Number15167337
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2010
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: 09/27/2017 Patient Sequence Number: 1
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