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

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the trapease filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to perforation and tilt, that causes injury and damage to the patient.The indication for filter placement is not available.The filter remains implanted; thus, unavailable for analysis.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 brief, the trapease filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: perforation and tilt, that causes injury and damage to the patient.

Manufacturer Narrative

As reported, the trapease inferior vena cava (ivc) filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to perforation of the ivc and tilt.Per the medical records, the indication for filter was pulmonary embolism (pe) with a strong family history of pe.And a contraindication for anticoagulation due to vaginal bleeding.The vena cava filter was deployed below the level of the renal veins.Post deployment cavagram revealed the filter in excellent position with no significant tilting or extravasation.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc and tilting of the ivc filter.The patient further reports living with the anxiety.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from ivc filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 brief, the trapease filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: perforation and tilt, that causes injury and damage to the patient.Per the patient¿s implant record, the filter was placed for pulmonary embolism (pe) and a strong family history of pe as the patient could not be fully anticoagulated due to vaginal bleeding.The patient was also obese.The vena cava filter was deployed below the level of the renal veins.Post deployment cavagram revealed the filter in excellent position with no significant tilting and no extravasation.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and nine months post implantation.The patient reports perforation of filter strut(s) outside the inferior vena cava (ivc) and tilting of the ivc filter.The patient further reports living with the anxiety of having a filter that could fail at any time, but that may not be retrievable without serious surgery, and living with the fear that the filter has tilted within the vena cava and perforated outside the vena cava.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8620297
• MDR Text Key: 145389982
• Report Number: 1016427-2019-02865
• 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
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• 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: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.035 WIRE; UNK 6FSHEATH
• Patient Outcome(s): Life Threatening