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

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2019

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 filter tilt.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 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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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.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, and/or wrongful death to the patient, including, but limited to: physical and emotional damages from tilt of the filter 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of varicocele repair, left knee arthroscopic surgery.According to the medical record, the patient presented to the emergency room (er) five days before the index procedure with progressively worse shortness of breath.Evaluation showed bilateral pulmonary embolism with right heart strain.The patient was also noted to have abnormally elevated liver function enzymes.The patient was seen in the er a week earlier for chest pain and shortness of breath.A cardiology workup was performed and found mild non-obstructive coronary artery disease of first obtuse marginal.The indication for the filter placement was massive pulmonary embolism, bilaterally and deep venous thrombosis of the left leg.The patient was also noted to have had lymphadenopathy of the right groin.An excision of right groin lymph node mass was initially performed followed by placement of the ivc filter through a small incision in the greater saphenous vein.The filter was deployed at lumbar spine 3, perpendicularly and correctly.The incision in the saphenous vein was closed with 5-0 prolene suture.It was noted that the patient¿s arterial blood gas preoperatively was 47, indicating hypoxia.After the filter implant the vital signs were stable except for pulse oximetry which was increasing progressively.The live enzymes increased on the day of the implant, a ct scan was performed and noted small ascites, and a small right pleural effusion.The patient was transferred to the intensive care unit.An echocardiogram was performed and showed worsening right ventricle dilation and hypokinesis, from an echocardiogram that was performed 2 days earlier.The family had the patient transferred to a different facility.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported events approximately eleven years and four months after the index procedure.The patient also reported mental anguish related to the filter.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of variocele repair and left knee arthroscopic surgery.The patient presented to hospital with chest pain and shortness of breath.Diagnostic testing revealed mild non-obstructive coronary artery disease of the first obtuse marginal artery.A week later, the patient again presented to hospital with progressively worsening shortness of breath.Diagnostic testing revealed bilateral pulmonary embolism (pe) with right heart strain, elevated liver enzymes and hypoxia.The indication for the filter placement was reported to be the massive bilateral pe along with left lower extremity deep vein thrombosis (dvt).The patient was also noted to have lymphadenopathy involving the right groin requiring excision of the right groin lymph node.The filter was implanted via the greater saphenous vein and placed at the level of l3.Post-procedurally, the patient¿s hypoxia and liver enzymes worsened progressively.A computerized tomography (ct) scan noted a small amount of ascites and a small right pleural effusion.The patient was transferred to the intensive care unit where an echocardiogram revealed worsening right ventricular dilation and hypokinesis when compared to a study that had been performed two days later.More than eleven years after the filter implantation, the patient underwent a ct scan that revealed that the filter was tilted with the tip approximately 2.1cm below the lowest renal vein.There was no evidence of perforation, fracture or stenosis.The patient further reported having experienced 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 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 filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55 CMCSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33152
• MDR Report Key: 12135555
• MDR Text Key: 260498169
• Report Number: 1016427-2021-05059
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: 466P306AU
• Device Lot Number: R0208114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 106