MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Complete Blockage (1094)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Edema (1820); Occlusion (1984); Thrombosis (2100)

Event Date 09/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the legal team, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: post-implant dvt/pe.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result.Patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the filter was implanted at the level of the superior endplate of the l2 vertebral body due to dvt.The patient tolerated the procedure well.Per the patients¿ medical records, the patient¿s medical history included dvt, pancreatitis, neuropathy, gastritis, djd, bipolar disorder, back pain, and arthritis.Approximately four years post implantation, the patient presented with bilateral lower extremity swelling.The patient said that he had developed swelling with pain on the right leg greater than left.A venogram was performed which showed some clot in the ivc filter.The venogram demonstrated that there was clot all the way from the femoral vein and the physician believed it went up to the common femoral vein, external, and common iliacs all the way up to the ivc; there was clot in the ivc and there was subacute clot in the ivc and the rest of it in the common and external iliacs were acute.The patient had tpa infusion overnight and presented for repeat imaging the next day.The patient reported improvement of his edema but persistent pain in his legs bilaterally.There was extensive thrombus present in the lower extremity veins bilaterally and ivc.The popliteal and femoral vein appeared better, but the iliac veins and ivc appeared worse.Imaging performed from the ivc (through the filter) into the r popliteal vein showed the ivc filter was occluded and worse than the day before.There was extensive clot present with occasional open lumen visualized.The patient was referred for potential angiovac therapy.During the same hospitalization, the patient experienced chest pain.Coronary artery calcification was present.There was bullous emphysema.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from anxiety.

Manufacturer Narrative

Corrected data: product code.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of trapease vena cava filter.The patient¿s medical history included dvt, pancreatitis, neuropathy, gastritis, djd, bipolar disorder, back pain, and arthritis.Per the medical records, the filter was implanted at the level of the superior endplate of the l2 vertebral body due to dvt.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: post-implant dvt/pe.Approximately four years post implantation, the patient presented with bilateral lower extremity swelling with pain, greater in the right leg than the left.A venogram showed there was clot from the common femoral vein, external, and common iliacs up to the ivc; and in the ivc.There was subacute clot in the ivc; however, in the common and external iliacs the thrombus was acute.A tpa infusion was done overnight with repeat imaging the next day.The patient reported improvement of his edema but persistent pain in his legs bilaterally.Repeat imaging showed extensive thrombus present in the lower extremity veins bilaterally and ivc.The popliteal and femoral vein appeared better, but the iliac veins and ivc appeared worse.Imaging performed from the ivc (through the filter) into the r popliteal vein showed the ivc filter was occluded and worse than the day before.There was extensive clot present with occasional open lumen visualized.The patient was referred for potential angiovac therapy.During the same hospitalization, the patient experienced chest pain.Coronary artery calcification and bullous emphysema was present on imaging.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from anxiety.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.Blood clots, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and anxiety 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.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8233241
• MDR Text Key: 132596440
• Report Number: 1016427-2019-02384
• 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,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F ANGIOGRAPHIC CATHETER; SHEATH; 6F ANGIOGRAPHIC CATHETER; SHEATH
• Patient Age: 54 YR