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

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to multiple fragments of the filter as well as an embedded apex that would now allow the filter to be retrieved.Multiple attempts to retrieve were not successful and the patient experienced significant pain.Eventually, a successful complex filter retrieval using a combination of the laser sheath and forceps occurred that required additional loop snare retrieval of embolized filter fragment in the left pulmonary artery.This additional retrieval attempt resulted in a non-flow limiting intimal injury of the inferior vena cava.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.The instructions for use (ifu) states filter fracture / separation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Injury to the ivc is a known potential event associated with the filter device, and in this case may be related to the reported fracture.Pain 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 team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to multiple fragments of the filter as well as an embedded apex that would now allow the filter to be retrieved.Multiple attempts to retrieve were not successful and the patient experienced significant pain.Eventually, a successful complex filter retrieval using a combination of the laser sheath and forceps occurred that required additional loop snare retrieval of embolized filter fragment in the left pulmonary artery.This additional retrieval attempt resulted in a non-flow limiting intimal injury of the inferior vena cava.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8565942
• MDR Text Key: 143590426
• Report Number: 1016427-2019-02769
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• 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
• Patient Outcome(s): Life Threatening