MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Fever (1858); Occlusion (1984); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease filter.The filter subsequently malfunctioned and caused injury and/or damage including but not limited to, filter migration, tilt, and perforation of the patient¿s vena cava causing extreme pain and thrombosis.The patient is reported to have required multiple procedures including stenting of the vena cava.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.Without images or procedural films for review, the reported filter migration/tilt could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.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 includes 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.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.The timing and mechanism of the reported filter tilt could not be determined.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Thrombosis within the ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease filter.The filter subsequently malfunctioned and caused injury and/or damage including but not limited to, filter migration, tilt, and perforation of the patient¿s vena cava causing extreme pain and thrombosis.The patient is reported to have required multiple procedures including stenting of the vena cava.

Manufacturer Narrative

 as reported by the legal brief, the patient underwent placement of a trapease filter.The filter subsequently malfunctioned and caused injury and/or damage including but not limited to, filter migration, tilt, and perforation of the patient¿s vena cava causing extreme pain and thrombosis.The patient is reported to have required multiple procedures including stenting of the vena cava.  additional information received per the medical records indicate that the patient was admitted to the hospital for recurrent deep vein thrombosis (dvt) with left leg pain.The next day the patient had a right heart catheterization, pulmonary angiogram, inferior vena cava (ivc) venogram and ivc filter implant.The filter was placed below the renal veins.There were no reports of complications   sixteen weeks after the index procedure, the patient was admitted to the hospital with intractable back pain secondary to an on the job injury and recurrent deep vein thrombosis of the legs.A lung scan was done that determined there was a low probability of pulmonary emboli.During the hospitalization, the patient developed increasing leg swelling and ran a fever that was treated with antibiotics.The patent was treated with a heparin drip and by adjusting the anticoagulant regimen and discharged home on an adjusted dosage.The patient was tested and was negative for factor v deficiency.Eight years and ten months after the index procedure, the patient was admitted to the hospital with a diagnosis of inferior vena cava occlusion and post-thrombotic syndrome.A venogram was performed that demonstrated occluded bilateral iliac veins, ivc and filter.Predilation was done to the bilateral iliofemoral veins and ivc.Then, deployment of stents to bilateral iliofemoral vein and ivc.  to complete the procedure, post balloon angioplasty to bilateral iliofemoral vein and ivc (12x40) was performed.The patient was discharged on an anticoagulant regimen.  eight years and ten months after the index procedure, the patient was admitted to the hospital with a diagnosis of post-thrombotic syndrome with left iliofemoral vein stent and ivc filter thrombosis.The patient reported progressive pain, night cramps and swelling of the legs.Catheter directed mechanical thrombolysis and infusion of thrombolytics was performed on the left femoral and iliac vein, within the indwelling iliac stent.A new stent was deployed within the existing stent with post placement angioplasty.Imaging revealed patency of the inferior vena cava at the level of the filter above the filter.The patient tolerated the procedure without report of complications.The patient was discharged on an anticoagulant regimen.A computed tomography (ct) done four days later shows the ivf filter was just below the level of the renal veins.  nine years after the index procedure, the patient had collateral vessel formation in the legs and abdomen.  nine years and three months after the index procedure, the patient was admitted to the hospital with a diagnosis of post-thrombotic syndrome and vascular occlusion.The patient was treated with bilateral femoral re-operative exposure.  the patient had femoral vein to femoral vein bypass graft thrombectomy, left femoral anastomotic patch repair, and a left femoral av fistula creation.There were no reports of complications.  after these procedures, it was reported that the patient had blisters on the left inner thigh, some opened after removal of the vac dressings, the vac was discontinued due to these blisters.  additional information received per the patient profile form (ppf) states that the filter had tilted, was unable to be retrieved and there were blood clots, clotting and/or occlusion of the ivc.There are no documented retrieval attempts.The patient reports mental anguish, fear of the filter breaking apart, fear of death from the filter and depression.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc)filter.Per the medical records, the patient was admitted to the hospital for recurrent deep vein thrombosis (dvt) with left leg pain.The next day the patient had a right heart catheterization, pulmonary angiogram, inferior vena cava (ivc) venogram and ivc filter implant.The filter was placed below the renal veins.There were no reports of complications.The filter subsequently malfunctioned and caused injury and/or damage including but not limited to, filter migration, tilt, and perforation of the patient¿s vena cava causing extreme pain and thrombosis.The patient is reported to have required multiple procedures including stenting of the vena cava.Sixteen weeks after the index procedure, the patient was admitted to the hospital with intractable back pain secondary to an on the job injury and recurrent deep vein thrombosis of the legs.A lung scan was done that determined there was a low probability of pulmonary emboli.During the hospitalization, the patient developed increasing leg swelling and ran a fever that was treated with antibiotics.The patent was treated with a heparin drip and by adjusting the anticoagulant regimen and discharged home on an adjusted dosage.The patient was tested and was negative for factor v deficiency.Eight years and ten months after the index procedure, the patient was admitted to the hospital with a diagnosis of inferior vena cava occlusion and post-thrombotic syndrome.A venogram was performed that demonstrated occluded bilateral iliac veins, ivc and filter.Predilation was done to the bilateral iliofemoral veins and ivc.Then, deployment of stents to bilateral iliofemoral vein and ivc.To complete the procedure, post balloon angioplasty to bilateral iliofemoral vein and ivc (12x40) was performed.The patient was discharged on an anticoagulant regimen.Eight years and ten months after the index procedure, the patient was admitted to the hospital with a diagnosis of post-thrombotic syndrome with left iliofemoral vein stent and ivc filter thrombosis.The patient reported progressive pain, night cramps and swelling of the legs.Catheter directed mechanical thrombolysis and infusion of thrombolytics was performed on the left femoral and iliac vein, within the indwelling iliac stent.A new stent was deployed within the existing stent with post placement angioplasty.Imaging revealed patency of the inferior vena cava at the level of the filter above the filter.The patient tolerated the procedure without report of complications.The patient was discharged on an anticoagulant regimen.A computed tomography (ct) done four days later shows the ivf filter was just below the level of the renal veins.Nine years after the index procedure, the patient had collateral vessel formation in the legs and abdomen.Nine years and three months after the index procedure, the patient was admitted to the hospital with a diagnosis of post-thrombotic syndrome and vascular occlusion.The patient was treated with bilateral femoral re-operative exposure.The patient had femoral vein to femoral vein bypass graft thrombectomy, left femoral anastomotic patch repair, and a left femoral av fistula creation.There were no reports of complications.After these procedures, it was reported that the patient had blisters on the left inner thigh, some opened after removal of the vac dressings, the vac was discontinued due to these blisters.Additional information received per the patient profile form (ppf) states that the filter had tilted, was unable to be retrieved and there were blood clots, clotting and/or occlusion of the ivc.There are no documented retrieval attempts.The patient reports mental anguish, fear of the filter breaking apart, fear of death from the filter and depression.The filter is 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.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 includes 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Blood clots, clotting and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Fever does not represent a device malfunction and may be related to underlying patient related issues.Collateral circulation, leg swelling, blisters and pain do not represent a device malfunction and may be related to underlying patient related issues.Anxiety and depression 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: UNKNOWN TRAPEASE FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7516044
• MDR Text Key: 108352056
• Report Number: 1016427-2018-01453
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2018

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/30/2018; 07/05/2018
• Supplement Dates FDA Received: 06/28/2018; 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 48 YR
• Patient Weight: 84