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

Model Number 466P306X

Device Problems Fracture (1260); Migration (4003)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263); Thromboembolism (2654); No Code Available (3191)

Event Date 07/28/2017

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 perforation of the inferior vena cava (ivc) filter struts, migration of the filter, caval thrombosis, post-thrombotic syndrome, blood clots/clotting and stenosis.The indication for the filter implant has 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 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 pe via percutaneous placement in the ivc 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.Blood clots, clotting, caval thrombosis and/or occlusion and stenosis do not indicate a device malfunction.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Rather, patient, pharmacological factors and/or vessel characteristics may have contributed to these events.Without images or procedural films for review, the reported filter migration and ivc perforation could not be confirmed and the exact cause could not be determined.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the 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 ivc 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.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.

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, perforation of the inferior vena cava (ivc) filter struts, migration of the filter, caval thrombosis, post-thrombotic syndrome, blood clots/clotting and stenosis.As a direct and proximate result, 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.

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 perforation of the inferior vena cava (ivc) filter struts, migration of the filter, caval thrombosis, post-thrombotic syndrome, blood clots/clotting and stenosis.The indication for the filter was pulmonary emboli.The filter was placed via the right common femoral vein and deployed at the level of l2.Imaging performed during the procedure revealed a patient cava.The patient tolerated the procedure well.The patient reports becoming aware of, perforation of filter strut(s) outside the ivc, migration of the entire filter other than to the heart, blood clots, clotting and or occlusion of the ivc, approximately five years and eleven months post implant.The patient also reports filter fracture, with fractured struts retained within the ivc, and that a computed tomography (ct) scan performed of the filter also reported fracture, perforation and migration.Later consultations noted caval thrombosis, thrombosis/embolism, blood clots, clotting and/or occlusion of the ivc, post thrombotic syndrome, leg swelling and stenosis.These injuries have caused emotional distress, mental anguish, anxiety and stress.There is currently no additional information available for review.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 pe via percutaneous placement in the ivc 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.Blood clots, clotting, caval thrombosis, embolism and/or occlusion and stenosis do not indicate a device malfunction.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Rather, patient, pharmacological factors and/or vessel characteristics may have contributed to these events.Without images or procedural films for review, the reported filter migration, fracture and ivc perforation could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) states that 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.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the 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 ivc 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.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.

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, perforation of the inferior vena cava (ivc) filter struts, migration of the filter, caval thrombosis, post-thrombotic syndrome, blood clots/clotting and stenosis.As a direct and proximate result, 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.Per the implant records, the filter was indicated for pulmonary emboli.Using ultrasound guidance, the patient underwent an inferior venacavagram.The right common femoral vein was accessed and the venacavagram revealed the cava to be patent, the takeoff of the renal veins at the level of l1-l2, a normal inferior vena cava and absence of clots.Following the cavagram the trapease filter was advanced and placed at the l2 level.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately five years and eleven months post implantation.The patient reports perforation of filter strut(s) outside the ivc, migration of the entire filter other than to the heart, blood clots, clotting and or occlusion of the ivc.The patient additionally reports fracture of the filter, with fractured filter struts retained within the ivc, and that a computed tomography (ct) scan performed of the trapease ivc filter also reported fracture, perforation and migration.Later consultations noted caval thrombosis, thrombosis/embolism, blood clots, clotting and/or occlusion of the ivc, post thrombotic syndrome, leg swelling and stenosis.These injuries have caused emotional distress, mental anguish, anxiety and stress.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9413088
• MDR Text Key: 169559227
• Report Number: 1016427-2019-03633
• 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
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR