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

Model Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problems Coagulation Disorder (1779); Dyspnea (1816); Occlusion (1984); Thrombosis (2100)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis.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.No additional information is available.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The trapease inferior vena cava (ivc) 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.A caval thrombosis and blood clots noted in the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis.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.No additional information is available.

Manufacturer Narrative

Reported lot number r07076381 could not be verified as a cordis lot number.

Manufacturer Narrative

Additional information was provided and is available in it was reported that a patient underwent placement of a trapease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis.Additional information provided on the patient profile form (ppf) indicated that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and caval thrombosis.The patient also reported to have experienced exertional dyspnea.The indication for the filter placement was bilateral pulmonary emboli (pe) with saddle emboli between the right and left main pulmonary arteries.Venous doppler ultrasound showed a superficial venous thrombosis in the left calf, there was no evidence for deep vein thrombosis (dvt).The patient had a laparoscopic banding procedure eighteen days prior to the filter placement and was sedentary the first week, after lifting something heavy in the garage the patient experienced chest pain.The patient reported to the emergency room with shortness of breath and was diagnosed with bilateral pe by computed tomography scan (ct).The patient also has a history or morbid obesity, hypertension, dyslipidemia, insulin resistance, esophagitis and right arthroscopic knee surgery.Findings reported in the procedural notes indicated that the patient had no evidence of thrombi in his pelvis or inferior vena cava but he did have very large collaterals feeding out of the right side of the pelvis consistent with an ileo-femoral dvt in the past.The patient is also reported to have known venous disease in the legs, but the patient denies a history of dvt.The patient had no evidence of dvt during this admission on ultrasound imaging but clinically has longstanding venous disease with varicosities and skin stasis changes.The filter was placed via the right femoral vein and was deployed just below the level of the renal veins.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.The trapease 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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.Dyspnea does not represent a device malfunction and may be related to underlying patient specific issues, specifically a prior history of pulmonary embolism.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently 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.

Manufacturer Narrative

Correction to (product code).

Manufacturer Narrative

Additional information was provided and is available in: (age at the time of event, date of birth), (event date), (event description), (relevant history race and medical history), (lot number), concomitant medical products and therapy dates (exclude treatment of event): boston scientific 6 french super sheath 11cm with.038 wire boston scientific.035 inch, bentson wire ptfe 150cm boston scientific 5 french mini-stick kit coaxial dilator set d-stat dry hemostatic bandage.(date received by the manufacturer), (evaluation codes): code for clotting (1779), occlusion (1984), dyspnea, the implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis.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.Additional information provided on the patient profile form (ppf)indicated that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and caval thrombosis.The patient also reported to have experienced exertional dyspnea.Information contained in the medical records indicated that the indication for the filter placement was bilateral pulmonary emboli (pe) with saddle emboli between the right and left main pulmonary arteries.Venous doppler ultrasound showed a superficial venous thrombosis in the left calf, there was no evidence for deep vein thrombosis (dvt).The patient had a laparoscopic banding procedure eighteen days prior to the filter placement and was sedentary the first week, after lifting something heavy in the garage the patient experienced chest pain.The patient reported to the emergency room with shortness of breath and was diagnosed with bilateral pe by computed tomography scan (ct).The patient also has a history or morbid obesity, hypertension, dyslipidemia, insulin resistance, esophagitis and right arthroscopic knee surgery.Findings reported in the procedural notes indicated that the patient had no evidence of thrombi in his pelvis or inferior vena cava but he did have very large collaterals feeding out of the right side of the pelvis consistent with an ileo-femoral dvt in the past.The patient is also reported to have known venous disease in the legs, but the patient denies a history of dvt.The patient had no evidence of dvt during this admission on ultrasound imaging but clinically has longstanding venous disease with varicosities and skin stasis changes.The filter was placed via the right femoral vein and was deployed just below the level of the renal veins.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7557950
• MDR Text Key: 109702672
• Report Number: 1016427-2018-01509
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2018
• Date Manufacturer Received: 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Weight: 125