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

Catalog Number 466P306X

Device Problem Fracture (1260)

Patient Problems Pain (1994); Distress (2329)

Event Date 06/21/2021

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 fracture of filter struts as shown by a computerized tomography (ct) scan of the chest, abdomen and pelvis completed about eighteen years and six months after the filter was implanted.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.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to fracture filter struts as shown by a computerized tomography (ct) scan of the chest, abdomen and pelvis completed about eighteen years and six months after the filter was implanted.As a direct and proximate result of this malfunction, the patient suffered 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a4, b4, b5, b6, b7, g2, g3, g6, h1, h2 and h6.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 of filter struts as shown by a computerized tomography (ct) scan of the chest, abdomen and pelvis completed about eighteen years and six months after the filter was implanted.According to the medical record the indication for the filter implant was recurrent pulmonary embolism.The patient had a history of deep vein thrombosis (dvt) and pulmonary embolism (pe) associated with oral contraceptives.The patient had been discharged from the hospital two days earlier for dvt and pe.The patient stood up and nearly passed out, had intense right sided chest pain and vomited what appeared to be clots.The patient was brought to the emergency room (er).Imaging was negative for pe; however, given the clinical picture it was decided to place an ivc filter.The patient also had an upper endoscopy, and no evidence of bleeding was found.The filter was placed with a 6fr access device via the right common femoral vein.The patient had multiple subsequent, non-filter related, hospital and doctor visits for issues of non-cardiac chest pain, abdominal pain, urinary tract infection, back pain and bell's palsy.Approximately nine years after the index procedure the patient presented to the er with complaints of right upper quadrant abdominal pain, nausea and vomiting.The physician notes indicated that this is a chronic problem with a medical history of irritable bowel syndrome.An ultrasound of the abdomen was negative for gallstones.The patient was discharged to follow up with primary care physician (pcp).The results of computed tomography (ct) scan done approximately seventeen years and nine months after the index procedure shows the ivc filter intact, in place just caudal to the renal veins.The indication for the scan was "broken filter." three days later the patient was seen in consult for evaluation of the ivc filter.The recommendation was for routine follow up in one year as the filter appeared stable and well positioned.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt) and pulmonary embolism (pe) associated with oral contraceptives.The indication for the filter implant was recurrent pulmonary embolism.The patient had been discharged from the hospital two days earlier for dvt and pe.The patient stood up and nearly passed out, had intense right sided chest pain and vomited what appeared to be clots.The patient was brought to the emergency room (er).Imaging was negative for pe; however, given the clinical picture it was decided to place an ivc filter.The patient also had an upper endoscopy, and no evidence of bleeding was found.The filter was placed with a 6fr access device via the right common femoral vein.The patient had multiple subsequent hospital and doctor visits for issues of non-cardiac chest pain, abdominal pain, urinary tract infection, back pain and bell's palsy.Approximately nine years after the index procedure the patient presented to the er with complaints of right upper quadrant abdominal pain, nausea and vomiting.The physician notes indicated that this is a chronic problem with a medical history of irritable bowel syndrome.An ultrasound of the abdomen was negative for gallstones.The patient was discharged to follow up with primary care physician (pcp).The results of computed tomography (ct) scan done approximately seventeen years and nine months after the index procedure shows the ivc filter intact, in place just caudal to the renal veins.The indication for the scan was "broken filter." a small non-obstructing right renal stone and right ovarian cysts were also observed.Three days later the patient was see in consult for evaluation of the ivc filter.The recommendation was for routine follow up in one year as the filter appeared stable and well positioned.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12179673
• MDR Text Key: 261913172
• Report Number: 1016427-2021-05092
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 109 KG