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

Model Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Stenosis of the esophagus (4487)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, a patient underwent placement of an unspecified vena cava filter manufactured by cordis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to perforation, tilting and stenosis.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of right leg deep venous thrombosis (dvt) with pulmonary embolus (pe).The lower abdomen and both groins were prepped and draped in the usual manner.Using a left femoral vein approach, the left femoral vein was cannulated using modified seldinger technique.A needle was introduced into the lumen of the left femoral vein and a guidewire was advanced under fluoroscopy to the inferior vena cava (ivc).A venocavogram was completed demonstrating a patent iliac vein and a patent inferior vena cava.A trapease inferior vena cava filter was deployed in the inferior vena cava under fluoroscopy at the level of the third lumbar vertebra.The repeat cavogram showed good position of the filter in the inferior vena cava.The patient tolerated the procedure well.

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 perforation, tilting and stenosis.The patient reported becoming aware of the events approximately thirteen years and eight months post implant.The patient also reported right side pain post implant and anxiety related to the filter.According to the medical record, the indication for the implant was right leg deep venous thrombosis (dvt) with pulmonary embolus (pe).The filter was placed via the left femoral vein and was deployed in the inferior vena cava under fluoroscopy at the level of the third lumbar vertebra.The repeat cavogram showed good position of the filter in the inferior vena cava.The patient tolerated the procedure well.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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Ivc filter tilt has been associated with practitioner technique and/or 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 reported events 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 perforation, tilt and stenosis could not be confirmed or further clarified.Due to the nature of the complaint the reported right-side pain could not be further clarified.Pain and anxiety do not represent 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

According to the information received in the patient profile form (ppf), the patient was implanted with a trapease ivc filter, and reports becoming aware of perforation of filter struts outside the ivc, tilting of the filter and stenosis, approximately thirteen years and eight months after the filter implantation.The patient further asserts to have suffered right side pain post implant and anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12262803
• MDR Text Key: 264716595
• Report Number: 9616099-2021-04750
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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: 466P306AU
• Device Lot Number: R0207128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK INTRODUCER CATHETER; UNK NEEDLE, UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR