MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter and an optease inferior vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant of the ivc filter.One of the filters was successfully removed, although it is unknown which one.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.The filters are unavailable for analysis.The products were not returned for analysis and the sterile lot numbers have not been provided; therefore, no device analysis nor device history record review could be performed.The optease and trapease vena cava filters are 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 and thrombosis within the filter do not represent a device malfunction.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.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1016427-2018-01367 and 1016427-2018-01368.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter and optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant of the ivc filter.One of the filters was successfully removed, although it is unknown which one.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.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.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter and an optease inferior vena cava (ivc) filter.Per the medical records for the trapease filter, the patient has a history of recent patellar tendon surgery with deep vein thrombosis throughout the right lower extremity with pulmonary embolism.The trapease filter was deployed via the groin into inferior vena cava at the l3-l4 level.During the same procedure, thrombolysis was done to remove multiple visible clots from throughout the left common femoral and superficial femoral veins.Clots that were in the popliteal vein and calf were not addressed at that time.The patient tolerated the procedures well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant of the ivc filter.One of the filters was successfully removed, although it is unknown which one.Approximately five months after implantation of the trapease filter the patient experienced inferior vena cava occlusion and complete occlusion of the trapease filter.Subsequently, the patient had a thrombectomy to remove chronic clots that were in various stages of chronicity and to remove chronic deep vein thrombi.The patient was also implanted with an optease vena cava filter at this time.Per the medical records for the optease filter, the patient has a history of patellar tendon surgery with deep vein thrombosis throughout the lower extremities with pulmonary embolism.Chronic clots, chronic deep vein thrombi, inferior vena cava occlusion and complete occlusion of a previously implanted trapease filter.During implantation of the optease filter the patient was having multiple procedures including cannulation of the right internal jugular, right popliteal vein, left popliteal vein; balloon angioplasty and angiojet thrombectomy.The patient was stable through all of the procedures.Per the patient profile form (ppf), the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava with the trapease filter.The form states that the filter has been in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.The form also states that the filters were unable to be retrieved, although the initial information states that one of the filters was explanted.However, there is no evidence which filter was removed.Per the patient profile form (ppf), the patient experienced anxiety and fear of possible device failure in the future.The filters are unavailable for analysis.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 optease and trapease vena cava filters are 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, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of patellar tendon surgery with deep vein thrombosis throughout the lower extremities with pulmonary embolism.Chronic clots, chronic deep vein thrombi, inferior vena cava occlusion and complete occlusion of a previously implanted trapease filter.During implantation of the optease filter the patient was having multiple procedures including cannulation of the right internal jugular, right popliteal vein, left popliteal vein; balloon angioplasty and angiojet thrombectomy.The patient was stable through all of the procedures. additional information received per the patient profile form (ppf) states that the patient experienced anxiety and fear of possible device failure in the future.The form noted that the filter has been in place for more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section b5:  additional information received per an amended patient profile form (ppf) states that the second device (optease filter) was successfully removed one month after it was implanted.The medical records state that the filter was no longer needed.The filter was removed in its entirety via the patient's right internal jugular vein.The patient was stable during the entire procedure.As reported, the patient had placement of a trapease inferior vena cava (ivc filter and an optease ivc filter.Per the medical records, the trapease filter, indicate the patient has a recent patellar tendon surgery with deep vein thrombosis throughout the right lower extremity with pulmonary embolism.The trapease filter was deployed at the l3-l4 level.During the same procedure, thrombolysis was done to remove multiple visible clots from throughout the left common femoral and superficial femoral veins.Clots that were in the popliteal vein and calf were not addressed at that time.The patient tolerated the procedures well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant of the ivc filter.One of the filters was successfully removed, although it is unknown which one.Approximately five months after implantation of the trapease, the patient experienced inferior vena cava occlusion and complete occlusion of the trapease filter.Subsequently, the patient had a thrombectomy to remove chronic clots and deep vein thrombi.Per the medical records for the optease filter, the patient had multiple procedures including filter implant, cannulation of the right internal jugular, right popliteal vein, left popliteal vein; balloon angioplasty and angiojet thrombectomy.Per the patient profile form (ppf), the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava with the trapease filter.The form states that the second device (optease filter) was successfully removed one month after it was implanted.The medical records state that the filter was no longer needed.The filter was removed in its entirety via the patient's right internal jugular vein.The patient reports anxiety and fear.Neither device is available for analysis.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 optease and trapease vena cava filters are 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7426701
• MDR Text Key: 105337203
• Report Number: 1016427-2018-01368
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15132882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN 6-FRENCH SHEATH.; UNKNOWN GUIDE WIRE.; UNKNOWN MICRO-PUNCTURE SHEATH.
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR