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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL UNKNOWN VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number UNKFILTER
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problems Embolus (1830); Renal Failure (2041); Thrombosis (2100); Ulceration (2116); Coma (2417); Respiratory Failure (2484)
Event Date 09/17/2012
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter in or about the year of 2007. The optease filter subsequently malfunctioned and caused injuries and damages to the patient including, but not limited to deep vein thrombosis (dvt), of his inferior vena cava (ivc) filter and vena cava, limb threatening ulceration, compartment syndrome, acute renal failure and respiratory failure. 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. According to the plaintiff profile form (ppf) received on 4/10/18: the patient learned the filter and vein has become occluded and that the device could not be retrieved on august 2012. Approximately five years post implant date a retrieval attempt was made. A percutaneous removal procedure and an open abdominal procedure were attempted but were unsuccessful. The patient is suffering of pain as well as stress and anxiety due the filter still being in place. The filter completely occluded the patient¿s veins leading to life threatening venous ulceration. The patient had to undergo numerous procedures as a result, including inferior vena cava bypass, reoperation due to compartment syndrome. The patient had an open wound for extended period of time, was in a coma, and had respiratory failure, insertion of a trachea and other complications. On (b)(6) 2012 patient underwent abdominal exploration with exposure of inferior vena cava, right and left common iliac and external iliac veins. Placement of a left external iliac vein non-cordis stent balloon angioplasty of the stent, gore hybrid graft. Distal placement and anastomosis in the infrarenal ivc of a 6mm gore hybrid graft connected to the previously placed stent. Multiple inflammatory adhesions and scar tissue around the ivc cuff, making it a very complex case. Abdominal closure and debridement of right lower extremity venous ulcer soft tissue and skin measuring approximately 5 x 4 cm in size three days later the patient underwent exploratory laparoscopic with abdominal wash out. Placement of a large abdominal vac dressing for closure. This was an emergency procedure performed for life saving operation. The next day the patient underwent placement of 27 meter left internal jugular temporary dialysis catheter under ultrasound guidance. No deep vein thrombosis. Abdominal washout with abdominal exploration. Placement of a large abdominal wound vac for closure. Three days later the patient underwent closure of abdominal wall wound with looped pds and retention sutures. Approximately twenty one days after closure of the abdominal wall wound the patient underwent egd with biopsy and maloney dilatation. Grade iv erosive esophagitis, erosive gastritis, biopsy taken. Hypertensive upper esophageal sphincter status post esophageal dilatation. Patient continued on iv protonix 40mg every 12 hours.
 
Manufacturer Narrative
As reported, the patient underwent placement of an trapease inferior vena cava (ivc) filter. The indication for filter placement is not available. The optease filter subsequently malfunctioned and caused injuries and damages to the patient including, but not limited to deep vein thrombosis (dvt) of the filter and vena cava, limb threatening ulceration, compartment syndrome, acute renal failure and respiratory failure. According to the patient profile form (ppf), the filter and vena cava has become occluded and that the device could not be retrieved approximately 5 years post implantation. Approximately five years post implant date a retrieval attempt was made. A percutaneous removal procedure and open abdominal procedures were attempted but were unsuccessful. The vena cava was completely occluded, with venous ulceration. The patient had inferior vena cava bypass, then a reoperation due to compartment syndrome. Following the vena cava bypass, the patient had an open wound for a period of time, was in a coma, and had respiratory failure with tracheostomy. Per the medical records, the abdominal exploration was done with exposure of inferior vena cava, right and left common iliac and external iliac veins. Placement of a left external iliac vein non-cordis stent balloon angioplasty of the stent, gore hybrid graft. Distal placement and anastomosis in the infrarenal ivc of a 6mm gore hybrid graft connected to the previously placed stent. Multiple inflammatory adhesions and scar tissue around the ivc cuff, making it a very complex case. Abdominal closure and debridement of right lower extremity venous ulcer soft tissue and skin measuring approximately 5 x 4 cm in size. Three days later the patient underwent exploratory laparoscopic with abdominal wash out. Placement of a large abdominal vac dressing for closure. The next day, the patient a dialysis catheter was inserted for renal failure and dialysis treatment. Three days later, the patient underwent closure of abdominal wall wound with looped pds and retention sutures. The patient has anxiety. 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. Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined. Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Venous ulcers and compartment syndrome do not represent a device malfunction and may be related to underlying patient related coagulopathy issues. Acute renal failure, respiratory failure, coma and open wound do not represent device malfunctions and are directly related to the interventional surgery procedure and as such may have multiple contributing factors related to underlying patient condition, surgical procedure and medications administered. 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.
 
Event Description
As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter in or about the year of 2007. The optease filter subsequently malfunctioned and caused injuries and damages to the patient including, but not limited to deep vein thrombosis (dvt), of his inferior vena cava (ivc) filter and vena cava, limb threatening ulceration, compartment syndrome, acute renal failure and respiratory failure. 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. According to the plaintiff profile form (ppf) received on 4/10/18: the patient learned the filter and vein has become occluded and that the device could not be retrieved on august 2012. Approximately five years post implant date a retrieval attempt was made. A percutaneous removal procedure and an open abdominal procedure were attempted but were unsuccessful. The patient is suffering of pain as well as stress and anxiety due the filter still being in place. The filter completely occluded the patient¿s veins leading to life threatening venous ulceration. The patient had to undergo numerous procedures as a result, including inferior vena cava bypass, reoperation due to compartment syndrome. The patient had an open wound for extended period of time, was in a coma, and had respiratory failure, insertion of a trachea and other complications. On 9/17/12 patient underwent abdominal exploration with exposure of inferior vena cava, right and left common iliac and external iliac veins. Placement of a left external iliac vein non-cordis stent balloon angioplasty of the stent, gore hybrid graft. Distal placement and anastomosis in the infrarenal ivc of a 6mm gore hybrid graft connected to the previously placed stent. Multiple inflammatory adhesions and scar tissue around the ivc cuff, making it a very complex case. Abdominal closure and debridement of right lower extremity venous ulcer soft tissue and skin measuring approximately 5 x 4 cm in size three days later the patient underwent exploratory laparoscopic with abdominal wash out. Placement of a large abdominal vac dressing for closure. This was an emergency procedure performed for life saving operation. The next day the patient underwent placement of 27 meter left internal jugular temporary dialysis catheter under ultrasound guidance. No deep vein thrombosis. Abdominal washout with abdominal exploration. Placement of a large abdominal wound vac for closure. Three days later the patient underwent closure of abdominal wall wound with looped pds and retention sutures. Approximately twenty-one days after closure of the abdominal wall wound, the patient underwent egd with biopsy and maloney dilatation. Grade iv erosive esophagitis and erosive gastritis were noted, and biopsy was done. The diagnosis was hypertensive upper esophageal sphincter status post esophageal dilatation. Patient continued on iv protonix 40mg every 12 hours.
 
Manufacturer Narrative
Please note that the exact event date is unknown and that the event date is the complaint awareness date. Please note that the date of implant was 2007. The exact date was not specified so (b)(6) 2007 was used due to system issues. Please note also that the type of filter is unknown at this time as both the trapease and optease filters were mentioned.   as reported through the legal department via legal brief, the plaintiff underwent placement of a trapease inferior vena cava (ivc) filter. The optease filter subsequently malfunctioned and caused injuries and damages to the plaintiff including, but not limited to: deep vein thrombosis (dvt), of his ivc filter and vena cava, limb threatening ulceration, compartment syndrome, acute renal failure and respiratory failure. As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available.   the product was not returned for inspection. Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.   the cordis optease® vena cava filter (filter) is designed for the prevention of recurrent pulmonary embolism via placement in the inferior vena cava (ivc). The self-centering optease filter is laser cut from nickel titanium alloy (nitinol) tubing. The proximal and distal baskets of the optease filter, which consist of struts in a six diamond-shape configuration, are designed for optimal clot capture. 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. 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. The reported events of limb threatening ulceration, compartment syndrome, acute renal failure, respiratory failure, and thrombus within the vessel (or in the filter) do not represent a device malfunction. Rather, patient and pharmacological factors may have contributed to these events. The product¿s instructions for use indicates that filter obstruction and thrombus formation are potential complications of filter implantation. Dvts are distinguished as being above or below the popliteal vein. Very extensive dvts can extend into the iliac veins or the inferior vena cava. Dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of your lower leg (calf), and can spread up to the veins in your thigh. Dvt can also first develop in the deep veins in your thigh and, more rarely, in other deep veins, such as the ones in your arm. Deep vein thrombosis is the result of three principal factors: reduced or stagnant blood flow in deep veins (venous stasis). Injury to the blood vessel wall. An increase in the activity of those substances in the blood that are part of the normal clotting mechanism, a condition called hypercoagulability (which means a more active clotting state). Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt. Inferior vena cava filters are used to prevent sequelae, especially pe, in patients with contraindications to, complications of, or failure of anticoagulation therapy and patients with extensive free-floating thrombi or residual thrombi following massive pe. Placement of a vena cava filter reduces, but does not eliminate the risk of symptomatic pe in patients with proximal dvt in the short-term and does not prevent small pe. Factors that may have influenced the event include patient, pharmacological and lesion. There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt. 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 legal brief, the plaintiff underwent placement of a trapease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injuries and damages to the plaintiff including, but not limited to: deep vein thrombosis (dvt), of his ivc filter and vena cava, limb threatening ulceration, compartment syndrome, acute renal failure and respiratory failure. As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available.
 
Manufacturer Narrative
The product catalog number was corrected to "unkfilter. "   additional information will be submitted within 30 days upon receipt.
 
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Brand NameUNKNOWN VENA CAVA FILTER
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary FL
EI
MDR Report Key6629345
MDR Text Key291485701
Report Number1016427-2017-00360
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKFILTER
Device Catalogue NumberUNKFILTER
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/10/2017
Event Location No Information
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/09/2017 Patient Sequence Number: 1
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