MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: perforation and tilt,.

Manufacturer Narrative

As reported, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: perforation and tilt.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The inferior vena cava (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 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, 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.The timing and mechanism of the tilt has not been reported at this time.The brief also reported a perforation; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.However, 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.

Manufacturer Narrative

As reported a patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused perforation and tilt.The patient subsequently reported becoming aware of inferior vena cava (ivc) and organ perforation, tilt, filter embedded and calcified densities within the lumen of the ivc, approximately sixteen years and eleven months post implant.The patient also reported anxiety related to the filter.According to the medical record the indication for the filter implant was a history of deep vein thrombosis with provocation of thrombus on anticoagulation.The filter was implanted via the right common femoral vein and deployed at the l2 level.Approximately fifteen years and nine months post implant a computed tomography (ct) scan was performed.The images were submitted for additional review approximately fourteen months after the scan was performed.The impression from the second review noted that the filter is tilted anteriorly at the superior end and is embedded within the ivc wall.All of the struts perforate the ivc up to 7mm.Two anterior struts perforate 5mm and 6mm and contact the bowel.One medial and one posterior strut perforate 5mm and reside within the soft tissues.One posterior strut perforates 5mm and contacts the l3 vertebral body.One lateral strut perforates 7mm and resides within the soft tissues.There is a calcific density within the lumen of the ivc filter, this may represent chronic calcification from long standing thrombus.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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Trapease ivc filters are indicated for permanent placement.Calcified thrombus within the device or the ivc and/or the vasculature does not represent a device malfunction.Clinical factors that may have influenced these events include pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filter tilt has been associated with practitioner technique and 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) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without post implant image reports the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt) with provocation of thrombus on anticoagulation.The patient was scheduled for the following procedures on the same day: catheter placement and placement of trapease filter.The filter was implanted via the patient's right common femoral vein.The filter was deployed at the l2 level.Computed tomography (ct) scan done approximately fifteen years and nine months after the index procedure were re-evaluated sixteen years and eleven months after the index procedure.The images revealed: the superior end of the filter is at the l2-l3 interspace.The filter is tilted anteriorly at the superior end and is embedded within the ivc wall.The ivc filter is not tilted at the inferior end.All of the struts perforate the ivc up to 7mm.Two (2) anterior struts perforate the ivc wall 5mm and 6mm and contacts the bowel.One (1) medial strut perforates the ivc wall 5mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 5mm and contacts the l3 vertebral body.One (1) posterior strut perforates the ivc wall 5mm and resides within the soft tissues.One (1) lateral strut perforates the ivc wall 7mm and resides within the soft tissues.There is a calcific density within the lumen of the ivc filter.The report states that this may represent chronic calcification from long standing thrombus.Additional information received per the patient profile form (ppf) states that the patient experienced inferior vena cava (ivc) perforation, organ perforation, filter tilt, filter embedded in wall of the ivc and calcified densities within the lumen of the ivc.These densities may represent chronic calcification from long standing thrombus.The patient became aware of the reported events approximately sixteen years and eleven months after the index procedure.The patient continues to experience anxiety related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 and h6.As reported a patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused perforation and tilt.The patient subsequently reported becoming aware of inferior vena cava (ivc) and organ perforation, tilt, filter embedded and calcified densities within the lumen of the ivc, approximately sixteen years and eleven months post implant.The patient also reported anxiety related to the filter.According to the medical record the indication for the filter implant was a history of deep vein thrombosis with provocation of thrombus on anticoagulation.The filter was implanted via the right common femoral vein and deployed at the l2 level.Approximately fifteen years and nine months post implant a computed tomography (ct) scan was performed.The images were submitted for additional review approximately fourteen months after the scan was performed.The impression from the second review noted that the filter is tilted anteriorly at the superior end and is embedded within the ivc wall.All of the struts perforate the ivc up to 7mm.Two anterior struts perforate 5mm and 6mm and contact the bowel.One medial and one posterior strut perforate 5mm and reside within the soft tissues.One posterior strut perforates 5mm and contacts the l3 vertebral body.One lateral strut perforates 7mm and resides within the soft tissues.There is a calcific density within the lumen of the ivc filter, this may represent chronic calcification from long standing thrombus.The product is unavailable 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Trapease ivc filters are indicated for permanent placement.Calcified thrombus within the device or the ivc and/or the vasculature does not represent a device malfunction.Clinical factors that may have influenced these events include pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filter tilt has been associated with practitioner technique and 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) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without post implant image reports the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8263022
• MDR Text Key: 133712732
• Report Number: 1016427-2019-02442
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2022

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: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0405080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 09/15/2022; 10/20/2022
• Supplement Dates FDA Received: 02/28/2019; 10/05/2022; 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BENTSEN WIRE; UNKNOWN LONG 6 FRENCH SHEATH; UNKNOWN PIGTAIL CATHETER; UNKNOWN SHORT 5 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female