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

Catalog Number 466P306X

Device Problem Fracture (1260)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 fracture.The indication for the filter placement, procedural dictation notes and medical history 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 provided is invalid; therefore, no device analysis nor device history record review could be performed.The trapease ivc 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.Without procedural films or post implant imaging available for review, the reported filter fracture could not be confirmed or further clarified.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.There is nothing in the information provided to suggest that the reported events are related to the design and/or 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 fracture.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of factor v leiden deficiency, pulmonary embolism, with bilateral recent deep vein thrombosis (dvt).The patient was on chronic coumadin therapy with therapeutic inrs.The patient also complained of some rectal bleeding.  the filter was deployed via the patient's right common femoral vein.A preprocedural venocavogram revealed that the inferior vena cava had a normal caliber.The bilateral renal veins were also identified.The filter was inserted so that the superior tip of the filter remained inferior to the bilateral renal veins.The patient was in stable condition after the procedure.  additional information received per the patient profile form (ppf) states that the patient experienced filter fracture.The patient became aware of the reported event approximately five years and four months after the index procedure.The patient also experienced pain (side, stomach, legs and arms), depression, migraines and swollen legs and arms.The patient also reported that they "fall a lot.".

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 fracture.The patient reported becoming aware of the event approximately five years and four months post implant.The patient also reported experiencing pain in the side, stomach, legs and arms, depression, migraines and swollen legs and arms.The patient also reported falling a lot.According to the medical record the patient has a history of factor v leiden deficiency, pulmonary embolism, with bilateral recent deep vein thrombosis (dvt).The patient was on chronic coumadin therapy with therapeutic inrs.The patient also complained of some rectal bleeding.The filter was placed via the right common femoral vein and deployed with the superior tip inferior to the bilateral renal veins.The patient was in stable condition after the procedure.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.The trapease ivc 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.Without procedural films or post implant imaging available for review, the reported filter fracture could not be confirmed or further clarified.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.Pain, swelling migraines and anxiety do not represent a device malfunction and may represent underlying patient specific issues.There is nothing in the information provided to suggest that the reported events are related to the design and/or 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: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12100419
• MDR Text Key: 259602724
• Report Number: 1016427-2021-05033
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5-FRENCH PIGTAIL CATHETER; UNKNOWN 5-FRENCH SHEATH; UNKNOWN FILTER SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR