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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306AU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 11/27/2019
Event Type  Injury  
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 perforation and two ventral side struts that efface the pancreas uncinate process.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, pain and suffering, and other damages.
 
Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date in date of event is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused inferior vena cava perforation.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿inferior vena cava perforation¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿possible long-term complications associated with filter implantation include, but are not limited to perforation of the vena cava wall.¿ additionally, the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Without images available for review the reported perforation could not be confirmed or further clarified.Since no lot number was provided a phr could not be generated.The limited information available for review does not suggest that the reported event is 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.Please note that this is the initial report for this product.
 
Manufacturer Narrative
As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and two ventral side struts that efface the pancreas uncinate process.The patient reported becoming aware of perforation of filter struts outside the ivc and that two ventral side struts efface the pancreas uncinate process, approximately thirteen years and seven months post implant.The patient also reported anxiety related to the filter.According to the implant record the patient had a preoperative diagnosis of left leg deep vein thrombosis (dvt).The filter was placed via the right common femoral vein and deployed below the left renal vein, after selective venogram was performed.The patient tolerated the procedure well.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 ivc 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 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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported event could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Section d4 (catalog number).
 
Event Description
Per the implant records, the patient was reported to have a preoperative diagnosis of left leg deep vein thrombosis (dvt).The patient was prepped and draped aseptically and a micropuncture needle was used for percutaneous access of the right common femoral vein.Under fluoroscopy, a micro wire, a micro sheath followed by a guidewire were passed into the center of the inferior vena cava (ivc).A cavogram was completed revealing adequate size of the vena cava but the renal veins were not clearly seen.A catheter was then passed into the left renal, and selective left renal venogram was done.The cordis trapease filter was deployed below the left renal vein.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and that two ventral side struts efface the pancreas uncinate process, becoming aware of these events approximately thirteen years and seven months after the filter implantation.The patient further experienced anxiety related to the filter.
 
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Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12700981
MDR Text Key281271948
Report Number9616099-2021-05009
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,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2008
Device Catalogue Number466P306AU
Device Lot NumberR1105653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2005
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNK COBRA CATHETER.; UNK COBRA CATHETER.; UNK MICRO SHEATH, UNK 0.35 J-GUIDEWIRE.; UNK MICRO SHEATH, UNK 0.35 J-GUIDEWIRE.; UNK NEEDLE, UNK MICRO WIRE.; UNK NEEDLE, UNK MICRO WIRE.; UNK.
Patient Outcome(s) Life Threatening;
Patient SexFemale
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