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 04/17/2019

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: including perforation and tilt, that causes injury and damage to the patient.

Manufacturer Narrative

Additional information was received and the patient information, device information and description of event was updated.Lot #: r0406355.Per the medical records, history includes dvt (deep vein thrombosis), pulmonary embolism while on anticoagulation, gastrointestinal bleeding post colectomy with inability to anticoagulate.Venography noted the ivc to be less than 30mm in diameter, and the trapease was deployed at the level of the l2-l3 disc space.Per the patient profile form (ppf), the patient reports the filter has tilted and there is perforation of the struts outside of the ivc.The patient became aware of these events on (b)(6) 2018.The patient further reports living with the anxiety of having a filter that could fail at any time, but that it may not be retrievable without serious surgery, also living with the fear that the filter has tilted within the vena cava and perforated outside of it.Anxiety was added to the patient code.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The product number was also provided as 466p306bu.It was reported that a trapease filter subsequently malfunctioned and caused perforation and tilt.The patient reportedly became aware of the events approximately eleven years and six months post implant.The patient also reports living with the anxiety of having a filter that could fail at any time, but that it may not be retrievable without serious surgery, also living with the fear that the filter has tilted within the vena cava and perforated outside of it.According to the medical records the indication for the filter implant was a history of deep vein thrombosis, pulmonary embolism, on anticoagulation, a gastrointestinal bleed status post colectomy and inability to anticoagulated.The filter was placed via he right femoral vein and deployed at the level of l2-l3.Prior to the filter deployment a venacavogram was performed and the inferior vena cava appeared to be somewhat dilated, less than 30mm in diameter.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 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 the anatomy of the vessel, 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 tilt and perforation has not been reported at this time and 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.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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8620351
• MDR Text Key: 145393359
• Report Number: 1016427-2019-02866
• 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,Followup
• Report Date: 08/22/2019

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: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening