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

Model Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/19/2019

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 perforation of all filter struts outside the wall of the ivc.The indication for the filter implant has 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 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.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 perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without post implant images available for review the reported perforation into surrounding tissue could not be confirmed or further clarified.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 patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of all filter struts outside the wall of the ivc.As a result of the malfunction, 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d11, g3, g4, g7, h1, h2 and h6.Cont.Section b5: previous code of perforation; new codes of fracture, tilt, perforation or organ, nervousness and anxiety 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 perforation of all filter struts outside the wall of the inferior vena cava (ivc).The patient reported becoming aware of filter fracture, perforation of the filter struts outside the ivc, perforation of filter struts into organs and tilt, approximately eleven years and seven months post implant.The patient also reported mental anguish, anxiety and nervousness with shaky hands when writing or typing.According to the medical records the indication for the filter placement was recent deep vein thrombosis of the left lower extremity while on coumadin.The patient¿s medical history is significant for coronary bypass surgery and aortic valve replacement.The filter was placed via the right femoral vein and deployed at the level of l2.The patient tolerated the procedure well and was taken to recovery in stable condition.A single view x-ray of the abdomen performed post implant indicated that the filter body was at the level of l3 and there was no bowel distension.A computed tomography (ct) scan was performed approximately eleven years and five months post implant.The images were then submitted for review approximately fourteen weeks later.The review of the images noted that the superior end of the ivc filter is at the l2-l3 interspace and is tilted anteriorly at the superior and inferior end and it does not contact the ivc wall.All the struts of the ivc filter perforate the ivc up to 4mm.Two anterior struts contact the bowel, one resides within the soft tissues, one posterior strut contacts the l3-l4 disc, one posterior and one lateral strut resides within the soft tissues.There is one (1) posterior fractured strut.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 with the anatomy of the vessel, specifically asymmetry and tortuosity.It was reported that there was perforation of the ivc and into adjacent organ; 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 and long-term complications related it ivc filters.Without procedural films or images for review the reported event(s) could not be confirmed or further clarified.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt in the left lower extremity while on anticoagulation treatment.The patient has a significant past surgical history for coronary bypass surgery and aortic valve replacement.The filter was deployed via the patient's right femoral vein.It was placed at the l2 level.The patient tolerated the procedure well and was taken to recovery in stable condition.  computed tomography (ct) scans done approximately eleven years and five months after the index procedure were evaluated eleven years and seven months after the index procedure.The superior end of the inferior vena cava (ivc) filter is at the l2-l3 interspace.The ivc filter is tilted anteriorly at the superior end and it does not contact the ivc wall.The ivc filter is tilted anteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 4mm.Two (2) anterior struts perforate the ivc wall both 4mm and contact the bowel.One (1) medial strut perforates the ivc wall 4mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 4mm and contacts the l3-l4 disc.One (1) posterior strut perforates the ivc wall 4mm and resides within the soft tissues.One (1) lateral strut perforates the ivc wall 4mm and resides within the soft tissues.There is one (1) posterior fractured strut.Additional information received per the patient profile form (ppf) states that the patient experienced one fractured filter strut, perforation of the filter struts outside the ivc, perforation of filter struts into organs and tilting of the filter.The patient became aware of the reported events eleven years and seven months after the index procedure.The patient reported that they feel mental anguish, anxiety, concern and nervousness (hand shakes when typing or writing).

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9842967
• MDR Text Key: 188521535
• Report Number: 1016427-2020-03936
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 14 GAUGE INTRODUCER NEEDLE; UNKNOWN DILATOR; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR