MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Injury (2348)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

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, the side struts of the inferior vena cava (ivc) filter are both compressed and fractured superiorly.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

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, the side struts of the inferior vena cava (ivc) filter are both compressed and fractured superiorly.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.According to the medical records, the patient was sent to the emergency room by the physician after a report of a deep vein thrombosis (dvt) from the distal one-third of the superficial femoral vein and the popliteal vein was received.Prior medical history was noted as crohn¿s disease, hypertension, asthma, osteoporosis, obesity, a pin in the left elbow, tonsillectomy, removal of rectal cyst, tubal ligation, hysterectomy, multiple bone surgeries, polyp removals, appendectomy, bowel resection, two tier fusion of c5-c6 and c6-c7, broken left leg with two screws to the fibula and subsequent removal, left calcaneal osteotomy with a peroneus longus transfer, repair of tibialis posterior tendon and lithotripsy.Per the implant records, the patient was moderately obese and had been diagnosed with deep vein thrombosis (dvt) of the leg and saddle pulmonary embolus, for which the inferior vena cava filter was indicated.Using fluoroscopy guidance, the patient had a satisfactory placement of a trapease filter above the vena cava bifurcation and below the renal vein and tolerated the procedure well.The medical records indicated that the patient underwent serial ultrasounds, scans and x-rays for evaluation and monitoring of kidney stones.The patient had a long history of kidney stones due to crohn¿s disease.A gallstone was detected in one of the scans and did not require surgery.Approximately eight years after the filter was implanted, the patient underwent a cystoscopy and stent removal after ureteroscopy manipulation with laser of five right renal stones.A neck ultrasound revealed a palpable lump at the right neck approximately nine years after the filter was implanted.The palpable area correlated with a normal morphology right carotid bulb.Review of the abdominal x rays taken approximately between six- and seven-years post implantation indicated that there is compression of the side struts of the filter, the subsequent x-ray, taken approximately seven years post filter implant, indicated compression of the side struts with fracture superiorly.No significant tilt was identified, and migration could not be evaluated.A pertinent computed tomography (ct) scan was recommended to further evaluate the filter.Two still frame images were provided and depict an ivc filter, no other details can be ascertained from the images.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and eight months post implantation.The patient reports fracture and compression of the ivc filter.According to the information received in the redacted-amended patient profile form (ppf), the patient further reports suffering from abdominal pain and mental anguish 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 the side struts of the inferior vena cava (ivc) filter are both compressed and fractured superiorly.According to the medical records, the patient was sent to the emergency room by the physician after a report of a deep vein thrombosis (dvt) from the distal one-third of the superficial femoral vein and the popliteal vein was received.Prior medical history was noted as crohn¿s disease, hypertension, asthma, osteoporosis, obesity, a pin in the left elbow, tonsillectomy, removal of rectal cyst, tubal ligation, hysterectomy, multiple bone surgeries, polyp removals, appendectomy, bowel resection, two tier fusion of c5-c6 and c6-c7, broken left leg with two screws to the fibula and subsequent removal, left calcaneal osteotomy with a peroneus longus transfer, repair of tibialis posterior tendon and lithotripsy.Per the implant records, the patient was moderately obese and had been diagnosed with deep vein thrombosis (dvt) of the leg and saddle pulmonary embolus, for which the inferior vena cava filter was indicated.Using fluoroscopy guidance, the patient had a satisfactory placement of a trapease filter above the vena cava bifurcation and below the renal vein and tolerated the procedure well.The medical records indicated that the patient underwent serial ultrasounds, scans and x-rays for evaluation and monitoring of kidney stones.The patient had a long history of kidney stones due to crohn¿s disease.A gallstone was detected in one of the scans and did not require surgery.Approximately eight years after the filter was implanted, the patient underwent a cystoscopy and stent removal after ureteroscopy manipulation with laser of five right renal stones.A neck ultrasound revealed a palpable lump at the right neck approximately nine years after the filter was implanted.The palpable area correlated with a normal morphology right carotid bulb.An independent/outside review of abdominal x-rays taken approximately six- and seven-years post implant indicated that there is compression of the side struts of the filter, the subsequent x-ray, taken approximately seven years post filter implant, indicated compression of the side struts with fracture superiorly.No significant tilt was identified, and migration could not be evaluated.A pertinent computed tomography (ct) scan was recommended to further evaluate the filter.Two still frame images were provided and depict an ivc filter, no other details can be ascertained from the images.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and eight months post implant.The patient reports fracture and compression of the ivc filter and abdominal pain and mental anguish related to the filter.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.Without post implant images for review the reported fracture and compressed struts could not be confirmed.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined, however the medical records indicate a history of abdominal pain related diagnoses.Anxiety and pain do 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9383506
• MDR Text Key: 168451428
• Report Number: 1016427-2019-03604
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1206118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK CATHETER; UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 109