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

Catalog Number 466P306X

Device Problem Fracture (1260)

Patient Problems Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); Bowel Perforation (2668)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter has grade 3 perforations of 10 and 12 o¿clock struts to duodenum, a grade 3 perforation of 2 o¿clock strut to abut aorta and a grade 3 perforation of 6 o¿clock strut to abut l3 vertebral body.There are multiple grade 1 perforations of remainder of struts.There are also displaced fractures of left and right anterior struts.The filter remains implanted; thus, unavailable for analysis.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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc and duodenum; 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 complications related it ivc filters.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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/final 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 filter has grade 3 perforations of 10 and 12 o¿clock struts to duodenum, a grade 3 perforation of 2 o¿clock strut to abut aorta and a grade 3 perforation of 6 o¿clock strut to abut l3 vertebral body.There are multiple grade 1 perforations of remainder of struts.There are also displaced fractures of left and right anterior struts.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 progressive deep vein thrombosis (dvt) despite proper anticoagulation therapy.The filter was deployed via the patient's right internal jugular vein.The patient tolerated the procedure well.Computed tomography (ct) scans done approximately seventeen years and ten months after the index procedure state that there are grade 3 perforations of 10 and 12 o'clock struts to duodenum.Grade 3 perforation of 2 o'clock strut to abut aorta.Grade 3 perforation of 6 o'clock strut to abut l3 vertebral body.Multiple grade 1 perforations were seen with the remaining struts.Collateral vessels were seen along the anterior abdominal wall and retroperitoneum.  additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the lower inferior vena cava and perforation of filter strut(s) outside the inferior vena cava (ivc).The patient became aware of the reported events seven years and ten months after the index procedure.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was dvt (deep vein thrombosis) while on anticoagulation.The filter was deployed via the patient's right internal jugular vein.There were no reports of complications.The report states that the filter subsequently malfunctioned including, but not limited to filter fracture, and perforation of the ivc, duodenum, aorta and vertebral body.A ct scan, approximately 18 years post implant reveals grade 3 perforations of 10 and 12 o'clock struts to duodenum.Grade 3 perforation of 2 o'clock strut to abut aorta.Grade 3 perforation of 6 o'clock strut to abut l3 vertebral body.Multiple grade 1 perforations were seen with the remaining struts.Collateral vessels were seen along the anterior abdominal wall and retroperitoneum.Per the patient profile form (ppf), the patient reports filter fracture and perforation of filter strut(s) outside the ivc.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.The instructions for use (ifu) states filter fracture with perforation 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.It was reported that there was perforation of the ivc and surrounding structural organs; 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 complications related it ivc filters.Collateral vessels do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.Section h6: patient code '2572' was used for 'collateral vessels '.

• 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: 10580703
• MDR Text Key: 208354085
• Report Number: 1016427-2020-04399
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 10/15/2020
• Patient Sequence Number: 1
• Treatment: 5 FRENCH OMNIFLUSH DIAGNOSTIC CATHETER; UNKNOWN 0.035 GUIDE WIRE; UNKNOWN 4 FRENCH MICROPUNCTURE SYSTEM; UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR