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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/17/2019

Event Type  Injury  

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 inferior vena cava (ivc) filter thrombosis.The indication for the filter implant, procedural details and medical history of the patient 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 thrombosis was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and occlusion of the device or vasculature do not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.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 team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but limited to: physical and emotional damages from ivc filter thrombosis and the resultant symptoms.As a direct and proximate result of these malfunctions.The patient suffered life-threatening injuries and damages and required medical care ad treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, d3, g3, g6, h1, h2 and h6.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 (ivc) filter thrombosis.The patient reported becoming aware of blood clots, clotting, and/or occlusion of the ivc, approximately six years and six months post implant.The patient also reported mental anguish related to the filter.According to the medical records the patient had a history of chronic constipation, rheumatoid arthritis, a dual lead pacemaker, hysterectomy and a ventriculoperitoneal shunt for normal pressure hydrocephalus.The indication for the filter implant was acute venous embolism and deep vein thrombosis.The filter was placed below the renal veins and above the bifurcation.There were no complications, and the patient tolerated the procedure well.Approximately six years and six months post implant an abdominal computed tomography (ct) scan was performed to evaluate the filter.The scan report noted that the ivc filter was at the appropriate location and orientation.The lumen of the filter was without a clot seen in the upper midportion.There was stenosis/occlusion of the ivc at the distal portion of the ivc filter and ivc junction.There were collateral veins in the right pelvis area to the right renal vein at the level of the kidneys, mild collaterals in the abdominal wall.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.Ivc filter thrombosis was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and occlusion of the device or vasculature, including stenosis, does not indicate a device malfunction.Collateral circulation develops as a result of inherent circulation patterns being obstructed.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.Anxiety does not constitute 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of chronic constipation, rheumatoid arthritis, dual lead pacemaker, hysterectomy and the patient has a ventriculoperitoneal shunt for normal pressure hydrocephalus.The indication for the filter implant was acute venous embolism and deep vein thrombosis.The filter was placed below the renal veins and above the bifurcation.There were no complications, and the patient tolerated the procedure well.  approximately six years and six months after the index procedure an abdominal computed tomography (ct) scan was performed to evaluate the filter.The scan report noted that the inferior vena cava (ivc) filter was at the appropriate location and orientation.The lumen of the filter was without a clot seen in the upper midportion.There was stenosis/occlusion of the ivc at the distal portion of the ivc filter and ivc junction.There were collateral veins in the right pelvis area to the right renal vein at the level of the kidneys, mild collaterals in the abdominal wall.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting, and/or occlusion of the ivc.The patient became aware of the reported events approximately six years and six months after the index procedure.The patient also reported that they experienced mental anguish related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b2, b3, b4, b5, b6, b7, d1, d4, d10, g1, g2, g3, g6, h1, h2, h4 and h6.Section h6: health effect - clinical code: code 4581 was used for collateral veins.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: RAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 12083703
• MDR Text Key: 258881020
• Report Number: 1016427-2021-05021
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

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 Expiration Date: 02/28/2014
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15358768
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 08/24/2021; 09/20/2021
• Supplement Dates FDA Received: 09/17/2021; 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5F ECHOTIP STAINLESS STEEL SHEATH.; UNKNOWN 0.035 BENTSON GUIDE WIRE.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR