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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306AU
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problems Cardiac Arrest (1762); Pulmonary Edema (2020); Anxiety (2328); Depression (2361)
Event Date 03/17/2016
Event Type  Death  
Manufacturer Narrative
The device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains. Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart. Approximately two years after the implant the portions of the filter were surgically removed from the heart. Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema. Additional information contained in court documents indicated that the patient was in a coma after a motorcycle accident and that the filter was implanted to prevent blood clots. It is unknown if the patient regained consciousness after the motorcycle accident or the condition of the patient leading up to the surgical removal of the device. The patient was prescribed insulin and another medication related to the patient¿s kidneys. A computerized tomography (ct) scan performed prior to the surgery showed that the filter was in the patient¿s heart. It was reported that, following the death of a patient implanted with a trapease vena cava filter, it was removed by a pathologist. The notification from the pathologist to the patient¿s attorney was received of a procedure involving removal of a foreign object in the right ventricle repair tricuspid. The report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter. The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen. The third portion is a single small wire, 1. 5 cm in length. At the request of the surgeon, the specimen will be returned to the o. R. Who will return to the manufacturer. " the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains. Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart. Approximately two years after the implant the portions of the filter were surgically removed from the heart. Approximately one month later the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema. Additional information contained in court documents indicated that the patient was in a coma after a motorcycle accident and that the filter was implanted to prevent blood clots. It is unknown if the patient regained consciousness after the motorcycle accident or the condition of the patient leading up to the surgical removal of the device. The patient was prescribed insulin and another medication related to the patient¿s kidneys. A computerized tomography (ct) scan performed prior to the surgery showed that the filter was in the patient¿s heart. There is currently no additional information available. The product was not returned for analysis. A review of the device history record (dhr) associated with lot 15964751 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event. Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed and the exact cause could not be determined. The timing and mechanism of the fracture and migration are unknown at this time. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. 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. Acute pulmonary edema and cardiac arrest are not representative of a device malfunction, with the limited information currently available it is not possible to determine what factors may have contributed to those events and the death of the patient. 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.
 
Manufacturer Narrative
After further review of additional information received. Additional medical records were received in reference to the patient¿s open heart surgery. The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter. Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium. On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle. The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles. The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition. The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection. The patient was discharged home, eleven days later. One month after the heart surgery, the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion. Approximately three and a half hours arrival the patient became diaphoretic, pale and was bradycardic. The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated. The patient was intubated and cpr carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced. The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia.   the medical records indicated that the patient also had a history of severe obstructive sleep apnea.
 
Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: event date is date of death. Describe event or problem: it was reported that, following the death of a patient implanted with a trapease vena cava filter, the filter was removed by a surgeon. At the request of the surgeon, the specimen will be returned to the operating room who will return to the manufacturer. " the device has not been returned to the manufacturer, but was released to a biomedical storage facility, where it currently remains. Additional information was received indicated that after implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart. The patient¿s medical history has been provided and is significant for chronic stage v renal disease, diastolic congestive heart failure, hypertension, type ii diabetes mellitus, anemia and obesity. Three days prior to the index procedure, the patient was in a motorcycle accident resulting in multiple rib fractures, bruised lung, and brain swelling. Approximately one year and ten months after the index procedure, the patient was prepared for insertion of a perm-cath, under fluoroscopy. However, it was noted that the trapease filter was "floating. " the procedure was aborted, and the patient was transferred to a different medical facility. The patient underwent open heart surgery for removal of foreign object from the right atrium and ventricle and tricuspid valve repair with annuloplasty and left subclavian placement of a temporary hemodialysis catheter. Surgical notes of the filter removal indicated that the filter was primarily in the right ventricle, with part of the filter protruding through the tricuspid valve and into the right atrium. On further exam it was noted that at least one of the wire prongs was endothelialized and scarred down into the ventricular septum and another wire was endothelialized mainly into the anterior leaflet of the tricuspid valve and papillary muscle. The filter was freed from the scar tissue meticulously, ensuring no damage to the valve or the papillary muscles. The filter was removed in totality, the patient tolerated the procedure well and left the operating suite in critical but stable condition. The post-operative course was uneventful other than some serosanguinous sternal incisional drainage, that tested negative for a wound infection. The patient was discharged home, eleven days later with home health services. The device was sent to pathology for analysis, the report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter. The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen. The third portion is a single small wire, 1. 5 cm in length. Approximately one month later the patient was brought to the emergency room via ambulance for complaints of shortness of breath on exertion. Approximately three and a half hours arrival the patient became diaphoretic, pale and was bradycardic. The patient was moved from the chair to a bed and was noted to be asystolic, cardiopulmonary resuscitation (cpr) was initiated. The patient was intubated and cpr was carried out for approximately forty five minutes, the patient¿s spouse did not want cpr continued any longer, cpr was held and the patient was pronounced. The diagnosis provided at the time was cardiac arrest, end stage renal disease, acute pulmonary edema, and hyperkalemia. The death record noted the cause of death as acute pulmonary edema, diabetes mellitus and end stage renal disease. There is currently no additional information available for review. 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. Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed, and the exact cause could not be determined. The timing and mechanism of the fracture and migration are unknown at this time. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. 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 death certificate listed the cause of death as acute pulmonary edema, diabetes and end stage renal disease. 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.
 
Manufacturer Narrative
This report is a follow up report to mfr number 9616099-2016-00331 that was submitted under the previous complaint handling software system. The information has been duplicated from the first report with additional information added. It was reported that a patient underwent implantation of a trapease inferior vena cava filter. The indication for the implant and the medical history of the patient have not been provided. It was reported that at some point after implant the filter fractured and migrated. The device was surgically removed during a procedure to remove a foreign body from the right ventricle and tricuspid repair, and then sent to pathology. The pathology report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter. The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen. The third portion is a single small wire, 1. 5 cm in length. Additional information indicated that approximately two years after implant portions of the device were surgically removed from the heart. Approximately one month after the procedure to remove the device the patient expired due to complications related to the filter including cardiac arrest and acute pulmonary edema. There is currently no additional information available. 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. Without procedural films for review, the reported filter fracture/separation and migration of the filter could not be confirmed and the exact cause could not be determined. The timing and mechanism of the fracture and migration are unknown at this time. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. 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. Acute pulmonary edema and cardiac arrest are not representative of a device malfunction, with the limited information currently available it is not possible to determine what factors may have contributed to those events and the death of the patient. 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 in the legal notice, following the death of the patient implanted with a trapease vena cava filter, it was removed by a pathologist. The notification from the pathologist to the patients attorney was received of a procedure involving removal of a foreign object in the right ventricle repair tricuspid. The report states, "received fresh and additionally designated as "foreign body" are three pieces of metal wires, the largest of which has an incomplete umbrella like configuration with two pointed ends, measuring 5 cm in height x 3 cm in central diameter. The second fragment has one branched wire and is 5 cm in length and seems to be part of the first portion of the specimen. The third portion is a single small wire, 1. 5 cm in length. At the request of the surgeon, the specimen will be returned to the o. R. Who will return to the manufacturer. " additional information was received that the device was implanted on (b)(6) 2014. After implantation, the ivc filter fractured and the fractured pieces/the entire device migrated to the other parts of the patient's body, including the heart. On (b)(6) 2016, the portions of the filter were surgically removed from the heart. On or about (b)(6) 2016, the patient died from complications related to the filter including cardiac arrest and acute pulmonary edema. Additional information received in the form of the device product code and lot number.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7126173
MDR Text Key105962997
Report Number1016427-2017-00883
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/22/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Catalogue Number466P306AU
Device Lot Number15964751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2017 Patient Sequence Number: 1
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