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

Catalog Number 466P306X

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2019

Event Type  Death  

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.(b)(4).As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement was not reported.The report states that the filter subsequently malfunctioned including, but not limited to filter fracture, tilt, organ perforation, and ivc stenosis.The patient is deceased, but there was no information was provided to regarding cause of death.The device is 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 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Death is a known potential complication associated with the use of the ivc filter devices and is listed in the ifu as such; however, in this case the cause of death was not reported; therefore, an adequate assessment of the relationship of the filter to the event of death is not possible.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 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 fracture, tilt, organ perforation, and inferior vena cava (ivc) stenosis.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.The patient is deceased, but there was no information provided to relate her demise to the device.

Event Description

Additional information received per the medical records indicate that the patient has a history of right lower extremity deep venous thrombosis with bilateral leg swelling.The filter was deployed via the patient's left femoral vein.It was placed just below the left renal vein.The filter was in a good position.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient experienced filter fractured within the inferior vena cava (ivc), tilt, perforation of filter struts into organs (the superior mesenteric and vertebral arteries), 50% stenosis, perforation of filter struts outside the inferior vena cava (ivc) into mesenteric fat by a distance of 7 mm and into vertebra by a distance of 3 mm, the vertebra perforation resulted in difficulty walking and device was unable to be retrieved.The patient became aware of the reported events approximately eleven years and six months after the index procedure.The patient 's son reported that due to the stenosis of the superior mesenteric artery (sma) the patient required a peg tube and was unable to walk due to the impact on the vertebral artery.There were no documented attempts to retrieve the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease inferior vena cava (ivc) filter.The report states that the filter subsequently malfunctioned including, but not limited to filter fracture, tilt, organ perforation, and ivc stenosis.The patient is deceased, but a cause of death was not provided.The patient profile form indicated that the patient experienced filter fracture within the inferior vena cava (ivc), tilt, perforation of filter struts into organs (the superior mesenteric and vertebral arteries), 50% stenosis of the superior mesenteric artery (sma), perforation of filter struts outside the inferior vena cava (ivc) and device was unable to be retrieved.However, there were no documented attempts to retrieve the filter.The patient¿s son reported becoming aware of the events approximately eleven years and six months post implant.The son also reported that the due to the stenosis of the sma the patient required a peg tube and was unable to walk due to the impact on the vertebral artery.According to the medical record the indication for the filter implant was right lower extremity deep vein thrombosis with bilateral leg swelling.The filter was placed via the left femoral vein and deployed just below the left renal vein.The patient tolerated the procedure well.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 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 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 and long-term complications related to ivc filters.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuousness.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.While stenosis of the sma was also reported, with the limited information provided the event could not be further clarified, not a cause determined.Since the filter is in the venous system, it is unlikely that it would have caused or contributed to the reported stenosis of the artery.It was also reported that due to the impact on the vertebral artery the patient was unable to walk, without knowing which artery or the specific details of the event a clinical determination cannot be made.Death is a known potential complication associated with the use of the ivc filter devices and is listed in the ifu as such; however, in this case the cause of death was not reported; therefore, an adequate assessment of the relationship of the filter to the event of death is not possible.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without procedural films or post implant images for review the reported event(s) 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.

• 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: 11581653
• MDR Text Key: 242705256
• Report Number: 1016427-2021-04852
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: 04/07/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18 GAUGE NEEDLE; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN PIG TAIL CATHETER; UNKNOWN SHEATH
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Weight: 59