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

Model Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problem Perforation of Vessels (2135)

Event Date 01/09/2018

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 brief, the patient underwent placement of an trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter is still in place, and recent studies confirm the filter now presents more risks than benefits, including an increased risk of forming a blood clot.The extent of the device failure has not been fully documented by the patient's treating medical provider(s).As a result of the malfunction, the patient has or may suffer life-threatening injuries and damages and require extensive medical care and treatment.The patient has or may suffer and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability and other losses.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots, and may need a risky surgery to attempt to remove the filter.The following additional information was received per the patient¿s medical records: the patient was admitted and diagnosed with acute cerebrovascular accident, status post an embolectomy; large pulmonary embolus; and bipolar disorder.The patient was noted to have hemorrhagic conversion.The patient was negative for dvt and an ivc filter was implanted in the suprarenal ivc due to her hemorrhage and unable to be placed on anticoagulation.There was prominent filling of what appeared to represent a left circumaortic renal vein or a very low lying left renal vein.There was no coaxial imaging through the abdomen at that time for comparison of that finding.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 3 years and 7 months post implantation.The patient reports that the filter has been in place for more than 90 days and is too risky to attempt retrieval.No retrieval attempt has been documented.A ct scan of the filter reported migration and perforation outside the ivc.The patient also reports back pain, anxiety, depression and mental anguish.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient had acute cerebrovascular accident, status post an embolectomy; large pulmonary embolus; and bipolar disorder.The patient was noted to have hemorrhagic conversion.The patient was negative for dvt and an ivc filter was implanted in the suprarenal ivc.There was prominent filling of what appeared to represent a left circumaortic renal vein or a very low lying left renal vein.The patient tolerated the procedure well.Per the patient profile form (ppf), the patient reports a ct scan of the filter reported migration and perforation outside the ivc.The patient also reports back pain, anxiety, depression and mental anguish.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 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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.It was reported that there was perforation of the ivc; 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Anxiety, depression and back pain 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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8343946
• MDR Text Key: 136281904
• Report Number: 1016427-2019-02514
• Device Sequence Number: 1
• Product Code: DQO
• 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: 02/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17076203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR