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

Catalog Number 466P306X

Device Problems Fracture (1260); Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: other, senior counsel, litigation.(b)(4).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 filter tilt, perforation, fracture and collapse.The filter is tilted medially at the superior.All the wall struts of the ivc filter perforate the ivc up to 9mm.One anterior strut perforates 6mm and contacts the bowel.One medial strut perforated the ivc wall 6mm and contacts the aorta and another resides in the soft tissues.One posterior strut perforates the ivc wall 9mm and contacts the l3 vertebral body.Two lateral struts perforate the ivc wall 4mm and 6mm and reside within the soft tissues.There are two medial fractured struts causing collapse of the ivc filter.Information received per a computed tomography (ct) scan report supports the previously reported information.Additionally, the scan revealed that the superior end of the filter was at the l2-l3 interspace.The patient subsequently reported stomach pain (cramps), nausea and vomiting.The implant procedural details, indication for filter placement and medical history have not been provided.There is currently no additional information available for review.The product remains implant and unavailable for analysis, 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.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.Perforation may impact adjacent organs.The ifu also states that 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.Filter collapse due to a fractured strut was also reported, without films available for review the reported events could not be confirmed or further clarified.Without post implant image reports the reported events could not be confirmed or further clarified.Stomach pain, nausea and vomiting do not represent a device malfunction and may be related to underlying patient specific issues and possible comorbidities.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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava (ivc) filter is tilted medially at the superior end, but does not contract the ivc wall.All the wall struts of the ivc filter perforate the ivc up to 9mm.One anterior strut perforates the ivc wall 6mm and contacts the bowel.One medial strut perforated the ivc wall 6mm and contacts the aorta.One medial strut perforates the ivc wall 6mm and resides within the soft tissues.One posterior strut perforates the ivc wall 6mm and resides within the soft tissues.One posterior strut perforates the ivc wall 9mm and contacts the l3 vertebral body.Two lateral struts perforate the ivc wall 4mm and 6mm and resides within the soft tissues.There are two medial fractured struts causing collapse of the ivc filter.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Information received per a computed tomography (ct) scan report supports the previously reported information.Additionally, the scan revealed that the superior end of the filter was at the l2-l3 interspace.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, ivc perforation, organ perforation and filter fracture (two medial fractured struts causing partial collapse of filter).The patient also reported experiencing stomach pain (cramps), nausea and vomiting.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14180353
• MDR Text Key: 291721223
• Report Number: 9616099-2022-05570
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female