MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199); Stenosis (2263); Ulcer (2274); Vascular System (Circulation), Impaired (2572)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.Approximately eleven years after implantation the patient underwent unsuccessful filter retrieval surgery and was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient including, but not limited to, the filter was embedded in the wall of the ivc and could not be removed.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, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.Without procedural films for review, the reported filter retrieval difficulty, unable to retrieve from the vessel wall, could not be confirmed.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The off-label use of this filter likely contributed to the retrieval difficulty experienced by the customer.Given the limited information available for review at this time, there is nothing to 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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.Approximately eleven years after implantation the patient underwent unsuccessful filter retrieval surgery and was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient including, but not limited to, the filter was embedded in the wall of the ivc and could not be removed.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, and pain and suffering, and other damages.

Manufacturer Narrative

Complaint conclusion: as reported, a patient underwent placement of the trapease vena cava filter.The information provided indicated that the filter was embedded and could not be removed, the filter fractured, and the patient has experienced stress and worry.Additionally, the patient has experienced severe pain and is now handicapped after the loss of the right leg due to damage of blood flow from the inferior vena cava (ivc) filter implant.The indication for the filter implant was multiple pulmonary embolisms (pe) while on coumadin.The patient had a history of spontaneous multiple bilateral pulmonary emboli, preceding the filter implant, while anticoagulated on coumadin.The filter was placed via the right common femoral vein.Imaging noted that the vena cava was of normal caliber and the renal veins were observed bilaterally at the l2 vertebral level.The filter was deployed at the upper cortical endplate of l3 to the upper cortical endplate of l4.Approximately eleven years post implant an unsuccessful percutaneous retrieval attempt was made.The records indicated that the retrieval attempt was made due to a chronic ivc filter, stenosis of the ivc and bilateral venous stasis disease with ulcers causing severe pain and hindering daily activities.The retrieval attempt was made through the right and left groins and right internal jugular vein.Access through the right and left groins was extremely challenging due to central stenosis of the inferior vena cava and extensive collateral formation, and access had to be performed using a percutaneous needle rendezvous with a snare extended into the groins via the right internal jugular venous access.Venoplasty of the right common illiac vein and inferior vena cava was performed using a 10 mm balloon.Multiple attempts were made to hook the filter using multiple different catheters and wires, then with endobronchial forceps.After many attempts, a wire was threaded through the superior portion of the ivc filter in 2 locations, and a laser sheath was advanced down over the superior aspect of the ivc filter.Multiple attempts were made to laser the ivc filter away from the side of the ivc, however the ivc filter remains in place with subsequent breaking of the ivc filter struts with loss of grip on the ivc filter by the wires.The filter appearance at termination of procedure was unchanged except for breakage of a few superior struts.Repeat venography of the ivc following the retrieval attempt was not performed.Imaging performed during the procedure noted that there was extensive stricturing of the ivc at the level of the ivc filter, most narrow at the level of the inferior lvc filter.Ultrasound imaging of the bilateral iliac veins noted chronic occlusion with extensive collateral formation.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 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.Without procedural films for review and the limited information provided, the reported filter embedded, and vena cava stenosis could not be confirmed, and the exact cause could not be determined.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.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.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.Review of the information provided suggests that manipulation of the device during the attempted removal procedure may have contributed to the reported fracture.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently 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.

Manufacturer Narrative

The implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.Approximately eleven years after implantation the patient underwent unsuccessful filter retrieval surgery and was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient including, but not limited to, the filter was embedded in the wall of the ivc and could not be removed.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, and pain and suffering, and other damages.Additional information provided on the patient profile form (ppf) alleged that the filter has fractured.Approximately eleven years post implant there was an unsuccessful percutaneous removal attempt.The patient is also reported to have stress and worry and has experienced severe pain and is now handicapped after the loss of the right leg due to damage of blood flow from the inferior vena cava (ivc)) filter implant.Information contained in the medical records indicated that the filter was placed due to multiple pulmonary embolisms (pe) while on coumadin.The filter was placed via the right common femoral vein.Imaging noted that the vena cava was of normal caliber and the renal veins were observed bilaterally at the l2 vertebral level.The filter was deployed at the upper cortical endplate of l3 to the upper cortical endplate of l4.Approximately eleven years later due to chronic ivc filter with stenosis of the ivc and severe bilateral venous stasis disease with ulcers causing severe pain and hindering daily activities.The patient had a history of spontaneous multiple bilateral pulmonary emboli, preceding the filter implant.While anticoagulated on coumadin the patient has developed multiple clots.The retrieval attempt was made through the right and left groins and right internal jugular vein.Access through the right and left groins was extremely challenging due to central stenosis of the inferior vena cava and extensive collateral formation, and access had to be performed using a percutaneous needle rendezvous with a snare extended into the groins via the right internal jugular venous access.Venoplasty of the right common illiac vein and inferior vena cava was performed using a 10 mm balloon.Multiple attempts were made to hook the nc filter using multiple different catheters and wires, then with endobronchial forceps.After many attempts, a wire was threaded through the superior portion of the ivc filter in 2 locations, and a laser sheath was advanced down over the superior aspect of the ivc filter.Multiple attempts were made to laser the ivc filter away from the side of the ivc, however the ivc filter remains in place with subsequent breaking of the ivc filter struts with loss of grip on the ivc filter by the wires.The filter appearance at termination of procedure was unchanged except for breakage of a few superior struts.Repeat venography of the ivc following the retrieval attempt was not performed.Imaging performed during the procedure noted that there was extensive stricturing of the ivc at the level of the nc filter, most narrow at the level of the inferior lvc filter.Ultrasound imaging of the bilateral iliac veins noted chronic occlusion with extensive collateral formation.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7450431
• MDR Text Key: 106157751
• Report Number: 1016427-2018-01418
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR