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

Catalog Number 466P306AU

Device Problems Material Perforation (2205); Output Problem (3005)

Patient Problem Perforation of Vessels (2135)

Event Date 08/02/2006

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, all six struts of the filter had perforated the vena cava and appeared extraluminally.The device was not returned for evaluation.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 event could not be conclusively determined.Procedural factors, such as operator technique, or vessel characteristics, although unknown, may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿complications may occur at any time during the procedure.Possible long-term complications associated with filter implantation include, but are not limited to, the following: filter obstruction, filter perforation of the vena cava wall, filter migration, filter fracture and/or recurrent pulmonary embolism.As no lot number or other product information was supplied a phr could not be completed.Without the return of the device, it is difficult to make a clinical conclusion between the device and the reported event based on the little information available.The ifu notes filter perforation of the vena cava wall as a long-term complication related to trapease filters.The information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to all six struts of the filter have perforated the vena cava and appear extraluminally.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have recently undergone brain surgery and subsequently developed left lower extremity deep vein thrombosis (dvt) involving the left common femoral vein and extending to the popliteal vein.Anticoagulation was not considered an option due to the patient¿s recent surgery.The filter was implanted via the right femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.Approximately five months after the filter implantation, the patient developed a mild dvt of the left popliteal vein and increased anxiety and depression.Approximately eight months after the filter implantation, the patient was noted to have limited compressibility of the left popliteal vein and minimal residual clot could not be ruled out.More than thirteen years after the filter implantation, the patient underwent a ct scan for an unspecified filter injury.The scan identified an ivc filter with all six struts located extraluminally by up to 8mm.One of the struts was noted to be located approximately 1.75cm from the right renal vein.There was no evidence of inflammation in the surrounding tissue or significant tilting or discontinuity.The patient further reported having experienced 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 trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (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 ivc perforation could not be confirmed and the exact cause could not be determined.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event 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

Per the implant records, the patient was reported to have a preoperative diagnosis of left common femoral deep venous thrombosis (dvt) to the popliteal vein with inability to anticoagulate because of recent brain surgery.The patient¿s right groin was prepped and draped in normal sterile fashion and the right femoral vein was accessed with a needle followed by placement of a guidewire and sheath in the inferior vena cava under direct fluoroscopy.An inferior venacavogram was performed ensuring placement was below the renal veins.The ¿greenfield filter¿ was then placed through the sheath up to the appropriate position which had been previously marked by the inferior venacavagram.The filter was deployed without any complications.The patient tolerated the procedure well.Approximately three months later, the patient was seen in a follow up visit for complaints of palpitations.About five months after the filter was implanted the patient underwent a bilateral lower extremity venous doppler indicated for dvt.Mild dvt of the left popliteal vein was reported.The patient history at the time included a history of extensive dvt, patient on coumadin therapy with a caval filter in place.The patient was also seen in office visit for increased anxiety/depression.About one week after the ultrasound, the patient had another office visit for complaints of urinary frequency, and was diagnosed with a uti.Approximately eight months post implant, a follow up venous doppler scan of the bilateral lower extremities was performed.Results noted normal exam except for the left popliteal vein which demonstrated limited compressibility, minimal residual clot could not be ruled out.Approximately one year and three months post implant a computerized tomography (ct) scan of the pelvis was performed for abdominal pain and vomiting with history of pancreatitis.Findings noted trace of free pelvic fluid in the right lower quadrant.An abdominal ultrasound was performed, the following day; results of the exam noted abdominal ascites and gall bladder wall thickening, probably related to the adjacent ascites.About thirteen years and four months after the filter was implanted, the patient underwent an abdominal ct scan indicated for an unspecified injury to the ivc.The scan identified an ivc filter with all six (6) struts located extraluminally.The most medial strut is the furthest extraluminally in position, approximately 8mm outside the wall of the ivc.The tip is located approximately 1.75 cm above the right renal vein.No surrounding inflammatory changes were appreciated; nor significant tilt seen or definite evidence of discontinuity.A noncalcified left lower lobe pulmonary nodule was reported as an incidental finding.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, becoming aware of this event approximately thirteen years and four months after the filter implantation and further experienced anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 12232888
• MDR Text Key: 263819891
• Report Number: 1016427-2021-05130
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2005
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0103911
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK NEEDLE, UNK GUIDEWIRE, UNK SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR