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

Catalog Number 466P306X

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 11/15/2019

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, deformed and fractured posterior side struts and the resultant symptoms.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 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.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the ifu.The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Deformed struts were also reported, due to the nature of the complaint and without images for review the event could not be further clarified.Without procedural films or post implant imaging available for review, the reported filter fracture, deformed and perforation could not be confirmed or further clarified.There is nothing to suggest that the reported event is 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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to physical and emotional damages from perforation, deformed and fractured posterior side struts and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to physical and emotional damages from perforation, deformed and fractured posterior side struts and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.According to the ivc radiological report received for review, a cordis type trapease ivc filter was identified based on the findings of the review, although imaging studies and records from the filter implantation were not provided and the exact implant date in unknown.An abdominal x-ray performed about nine years and six months after implantation demonstrated the filter at the superior l3 to inferior l4 interspace.Side struts were noted to be deformed and fractured.A computerized tomography (ct) scan of the abdomen/pelvis performed ten months after the x-ray reported the filter at the mid l3 to inferior l4 interspace.Migration was noted as unlikely based on the study and there was no significant tilt indicated.A grade 1 perforation was identified, and posterior side struts are noted to be deformed and fractured by anterosuperior l4 osteophyte.There was no significant change when ct results from this scan were used for comparison with two subsequent cts completed respectively about one-year and two-years later.Per the medical records received for review, the patient was reported to have a history of colon surgery, hernia repair, ileostomy and inferior vena cava (ivc) filter placement.The patient was noted to be to be a former smoker.No other details were provided.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, fractured filter struts retained by the anterosuperior l4 osteophyte, becoming aware of these events approximately twelve years and five months after the filter implantation.The patient further asserts to have suffered from leg swelling and abdominal pain post implant, and experienced anxiety related to the filter.

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, deformed and fractured posterior side struts and the resultant symptoms.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc), fractured filter struts retained by the anterosuperior l4 osteophyte, approximately twelve years and five months post implant.The patient also reported leg swelling, abdominal pain post implant, and anxiety related to the filter.Per the medical records the patient was reported to have a history of colon surgery, hernia repair, ileostomy and inferior vena cava (ivc) filter placement.The patient was noted to be to be a former smoker.No other details were provided.According to the ivc radiological report received for review, a cordis type trapease ivc filter was identified based on the findings of the review, although imaging studies and records from the filter implantation were not provided and the exact implant date in unknown.An abdominal x-ray performed about nine years and six months post implant demonstrated the filter at the superior l3 to inferior l4 interspace.Side struts were noted to be deformed and fractured.A computerized tomography (ct) scan of the abdomen/pelvis performed ten months after the x-ray reported the filter at the mid l3 to inferior l4 interspace.Migration was noted as unlikely based on the study and there was no significant tilt indicated.A grade 1 perforation was identified, and posterior side struts are noted to be deformed and fractured by anterosuperior l4 osteophyte.There was no significant change when ct results from this scan were used for comparison with two subsequent cts completed respectively about one-year and two-years later.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 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.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the ifu.The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Deformed struts were also reported, due to the nature of the complaint and without images for review the event could not be further clarified.Without procedural films or post implant imaging available for review, the reported filter fracture, deformed and perforation could not be confirmed or further clarified.Leg swelling, abdominal pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided a clinical determination of a relationship between the swelling and pain cannot be made.There is nothing to suggest that the reported event is 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 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12106386
• MDR Text Key: 259589551
• Report Number: 1016427-2021-05045
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR