MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Numbness (2415)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and perforation of all filter struts beyond the wall of the ivc and into surrounding organs/tissue, and fractures of multiple filter struts.The patient reported becoming aware of the events approximately fifteen years post implant.The patient also reported pain, numbness and anxiety related to the filter.According to the medical records, three computed tomography (ct) scans were performed post implant, the first one at eight years and nine months; second at nine years and ten months and the third at ten years and nine months.All three scan results indicated that the superior end of the filter is at the l2-3 interspace.The ivc filter is tilted anteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted posteriorly at the inferior end and it does not contact the ivc wall.All the struts of the ivc filter perforate the ivc up to 7mm.Two (2) anterior struts perforate the ivc wall 6mm and 7mm and contact the bowel.One (1) medial strut perforates the ivc wall 5mm, one (1) posterior strut and one lateral strut perforate the ivc wall 6mm and reside within the soft tissues.One (1) posterior strut perforates the ivc wall 5mm and contacts the l3 vertebral body.No thrombus is seen within the ivc.There is one (1) posterior and one lateral strut that is fractured.The indication for the filter placement, imaging and procedural details have not been provided and there is currently no additional information available for review.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 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.The instructions for use (ifu) states filter fracture 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.Ivc filter tilt has been associated operator technique and/or vessel anatomy, specifically asymmetry and tortuosity.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant images for review the reported event(s) could not be confirmed or further clarified.Numbness, pain and anxiety do 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

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 tilt and perforation of all filter struts beyond the wall of the ivc and into surrounding organs/tissue, and fractures of multiple filter struts.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering.And other damages.The following additional information received per the medical records indicate that, three ct scans were performed first one at eight years and nine months; second at nine years and ten months and third at ten years and nine months after the procedure.All three scan results indicated that the superior end of the cordis trapease permanent ivc filter is at the l2-3 interspace.The ivc filter is tilted anteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted posteriorly at the inferior end and it does not contact the ivc wall.All the struts of the ivc filter perforate the ivc up to 7mm.Two (2) anterior struts perforate the ivc wall 6mm and 7mm and contact 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 6mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 5mm and contacts the l3 vertebral body.One (1) lateral strut perforates the ivc wall 6mm and resides within the soft tissues.No hemorrhage seen.No thrombus is seen within the ivc.There is one (1) posterior fractured strut.There is one (1) lateral fractured strut.According to the information received in the patient profile from (ppf), the patient experienced numbness and slight pain; also suffer from psychological injuries or mental anguish related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 11021357
• MDR Text Key: 221822016
• Report Number: 1016427-2020-04622
• Device Sequence Number: 1
• Product Code: DTK
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 11/25/2020
• 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
• Patient Age: 49 YR