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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Swelling (2091); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)
Event Date 06/12/2020
Event Type  Injury  
Manufacturer Narrative
The catalog number is unknown; if received it will be provided.Complaint conclusion: 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 tilt, migration, perforation of filter strut(s), post thrombotic syndrome, pulmonary embolism (pe), leg swelling and pain post implant.The indication for the filter placement, procedural details and medical history have not been provided and there is 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 inferior vena cava (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.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.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).Factors that may have contributed to these events include pharmacological, patient and/or vessel characteristics.Without post implant images or procedural films for review, the reported filter tilt, migration, and perforation could not be confirmed, nor a cause determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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 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.Due to the nature of the complaint the reported pain could not be further clarified.Pain 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 by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt, migration, perforation of filter strut(s), post thrombotic syndrome, pe, lifetime anticoagulation, leg swelling and pain post implant.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.
 
Manufacturer Narrative
After further review of additional information received the following sections a2, b5, b7, g4, g7, h1,h2 and h6 have been updated accordingly.B5: addendum for additional information received:the following additional information received per the patient profile form (ppf) indicates that the patient reports that there was perforation of the filter struts outside of the inferior vena cava (ivc), migration of the entire filter to the heart, tilt and blood clots, clotting and or occlusion of the ivc.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.According to the patient medical records, the patient has a medical history of deep vein thrombosis (dvt) and pulmonary embolism, the patient was admitted with chest pain and shortness of breath.The patient had a diagnosis of acute pulmonary embolism with severe pulmonary hypertension.The trapease filter was then placed at the l2 level in the right iliac vein.The patient tolerated the procedure well.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.According to the medical records, history includes deep vein thrombosis (dvt) and pulmonary embolism, the patient was admitted with chest pain and shortness of breath.The patient had a diagnosis of acute pulmonary embolism with severe pulmonary hypertension.The trapease filter was then placed at the l2 level in the right iliac vein.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages including, but not limited to tilt, migration, perforation of filter strut(s), post thrombotic syndrome, pe, leg swelling and pain post implant.Per the patient profile form (ppf), the patient reports perforation outside of the ivc, migration of the entire filter to the heart, tilt and blood clots, clotting and or occlusion of the ivc and anxiety.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.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.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.Blood clots, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, leg swelling and 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.
 
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Brand Name
UNKNOWN TRAPEASE
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
MDR Report Key10209911
MDR Text Key197105774
Report Number1016427-2020-04105
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/03/2020
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 Number466P306X
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received06/29/2020
Supplement Dates Manufacturer Received08/19/2020
Supplement Dates FDA Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age63 YR
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