MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problem Perforation of Vessels (2135)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: 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 tilt of the filter, perforation of the inferior vena cava, and struts in close contact with the duodenum.The indication for the filter implant has not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.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 tilt and 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 filter tilt and perforation could not be confirmed or further clarified.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: physical and emotional damages from tilt of the filter, perforation of the inferior vena cava, struts in close contact with the duodenum, and the resultant symptoms.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.

Manufacturer Narrative

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 tilt of the filter, perforation of the inferior vena cava, and struts in close contact with the duodenum.The patient reported perforation of filter strut(s) outside the inferior vena cava (ivc).According to the medical record the patient has a history of recurrent pulmonary emboli, recurrent deep venous thrombosis, gastrointestinal bleed, iron-deficiency anemia, phlebitis left leg, hyperlipidemia, hypertension, coarctation of the aorta, an anterior wall myocardial infarction with stent and contraindications for anticoagulation.The filter was placed via the left common femoral vein and was deployed below the level of the renal veins.There were no complications, and the patient tolerated the procedure well.Approximately two months post implant the patient experienced edema and felt dizzy.Approximately five years and ten months post implant a computed tomography (ct) scan was performed.The scan revealed a large hiatal hernia and marked degenerative disc disease of the thoracolumbar spine.The filter was noted to be in a normal infrarenal placement with no tilting.The lateral struts appear to project outside the wall of the cava by 3 mm; however, this more likely represents tenting of the caval walls around the filter struts rather than a perforation.Although there was close apposition of the anterior filter struts near the posterior wall of the transverse duodenum there was no evidence of perforation of the duodenum.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.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 tilt and 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 filter tilt and perforation could not be confirmed or further clarified.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 a3 : patient gender is female.
.

Event Description

Additional information received per the medical records indicate that the patient has a history of recurrent pulmonary emboli, recurrent deep venous thrombosis, gastrointestinal (gi) bleed, iron-deficiency anemia, phlebitis left leg, hyperlipidemia (hld), hypertension, coarctation of the aorta (coa) anterior wall myocardial infarction (awmi) stent/coronary artery disease (cad) and the patient has contraindications for anticoagulation.The filter was deployed via the patient's left common femoral vein using ultrasound guidance.It was placed below the renal veins.There were no complications.The patient tolerated the procedure well.Additional information received per the medical records indicate that two months after the index procedure the patient experienced edema and felt dizzy.  the results of computed tomography (ct) scans done approximately five years and ten months after the index procedure indicate that the patient experienced chest pain prior to the scans.The scan revealed a large hiatal hernia and marked degenerative disc disease of the thoracolumbar spine.The filter was noted to be in a normal infrarenal placement with no tilting.The lateral struts appear to project outside the wall of the cava by 3 mm; however, this more likely represents tenting of the caval walls around the filter struts rather than a perforation.Although there was close apposition of the anterior filter struts near the posterior wall of the transverse duodenum there was no evidence of perforation of the duodenum.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc).

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11099807
• MDR Text Key: 225321549
• Report Number: 1016427-2020-04689
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN COMBINATION INTRODUCER AND ANGIOCATH; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR
• Patient Weight: 70