MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 05/02/2017

Event Type  Injury  

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 pulmonary embolism (pe), deep vein thrombosis (dvt), caval thrombosis, filter perforation and fracture.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 (dhr) review could be performed.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The trapease inferior vena cava filter is not indicated for use in the prevention of deep vein thrombosis.Without images or procedural films for review, the reported perforation and fracture could not be confirmed, and the exact causes could not be determined.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 complications related to ivc filters.The timing and mechanism of the perforation and fracture has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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.

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 damage to the patient including, but not limited to pulmonary embolism (pe), deep vein thrombosis (dvt), caval thrombosis, filter perforation and fracture.The patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate results, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

D11: unknown guidewire unknown sheath.A device history record (dhr) review of lot r1007002 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

The patient had a history of bilateral large pulmonary emboli and lower extremity deep venous thrombosis.The filter was implanted due to clot burden.The filter was deployed via the right common femoral vein.The ivc diameter was 20mm.The filter was successfully deployed in the infrarenal vena cava.The patient tolerated the procedure well.There were no procedural complications.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 8 years and 11 months post implantation.The patient reports fracture, perforation of filter strut(s) outside the ivc, blood clots and caval thrombosis.The patient also reports suffering from anxiety.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of large bilateral pulmonary emboli (pe) and lower extremity deep vein thrombosis (dvt).The indication for the filter placement was reported as due to clot burden.The filter was implanted via the right common femoral vein and was deployed in an infrarenal location.Additional information indicates that the inferior vena cava (ivc) had a diameter of 20mm in the area of filter deployment.The patient is reported to have tolerated the procedure well without procedural complications.Approximately eight years and eleven months after the implantation, the patient became aware that the filter had fractured, that strut(s) had perforated outside the ivc and was associated with blood clots and caval thrombosis.The patient also reported having experienced a dvt and pe.The patient further reported having experienced anxiety and mental anguish 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 pe via percutaneous placement in the 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 procedural films for review, the reported filter fracture could not be confirmed and the exact cause could not be determined.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Blood clots and thrombosis within the ivc vasculature do not represent a device malfunction.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.The reported ivc perforation could not be confirmed without procedural films for review.A review of the 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 these events include the patient¿s pre-existing comorbidities, pharmacological 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, 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8561947
• MDR Text Key: 143460288
• Report Number: 1016427-2019-02765
• Device Sequence Number: 1
• Product Code: DQO
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306X
• Device Lot Number: R1007002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/10/2019; 04/10/2019
• Supplement Dates FDA Received: 07/03/2019; 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 62 YR