MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF BRACH 90CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466P306BU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 inferior vena cava (ivc) wall perforation and stenosis.The indication for the filter implant has not been provided and there is currently 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 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 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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported perforation and stenosis could not be confirmed or further clarified.There is nothing to suggest that the reported event is related to the design and/or 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 report for this product.
Event or Problem Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to the filter perforates the inferior vena cava (ivc) wall and demonstrates stenosis.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, pain and suffering, and other damages.
Event or Problem Description
Additional information received per the medical records indicate that the patient has a history of chronic iron deficiency anemia, chest pain, left pleural effusion with atelectasis, elevated left hemidiaphragm, diabetes, gastric arteriovenous malformation, diverticulosis, hemorrhoids, adrenal insufficiency, paroxysmal atrial fibrillation, paraplegia secondary to a motor vehicle accident, post-traumatic stress disorder, allergic rhinitis, chronic pain syndrome, autonomic dysreflexia, neurogenic bladder (has a suprapubic catheter), seizures, homocystinemia, protein s deficiency, hiatal hernia, gastric reflux disease, gastric leiomyoma, cva x2, degenerative joint disease, mitral valve prolapse, insomnia, and hypercoagulable state.The indication for the filter placement was left leg deep vein thrombosis (dvt) and inability to anticoagulate due to drop in hematocrit and hemoglobin.The filter was deployed in the infrarenal inferior vena cava (ivc).Filter placement was immediately followed by placement of a peripherally inserted central catheter (picc) line via the right basilic vein.Nine days post implant, a magnetic resonance imaging (mri) of the abdomen was performed to rule out adenoma, no lesions were observed.Twelve days post implant a computed tomography (ct) scan of the abdomen and pelvis was performed due to a history of anemia, swollen leg and dvt.Results of the scan noted no pelvic masses or adenopathy, diffuse swelling of the left lower extremity and surgically absent uterus.The ivc filter is in place.Thirteen years and one month post implant, a ct scan of the abdomen was performed.The original radiology results were not provided.The images were submitted to additional review approximately two years after the scan was performed and noted ivc stenosis and 3mm mesenteric perforation.Additional information received per the patient profile form (ppf) states that the patient became aware of perforation of filter struts outside the inferior vena cava (ivc) and stenosis approximately thirteen years and one month post implant.The patient also reported shortness of breath, chest pain and tightness, migraines, nausea and fatigue related to the filter.
Additional Manufacturer Narrative
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 inferior vena cava (ivc) wall perforation and stenosis.The patient reported becoming aware of the events approximately thirteen years and one month post implant.The patient also reported shortness of breath, chest pain and tightness, migraines, nausea and fatigue related to the filter.According to the medical record the patient had a history of chronic iron deficiency anemia, chest pain, left pleural effusion with atelectasis, elevated left hemidiaphragm, diabetes, gastric arteriovenous malformation, diverticulosis, hemorrhoids, adrenal insufficiency, paroxysmal atrial fibrillation, paraplegia secondary to a motor vehicle accident, post-traumatic stress disorder, allergic rhinitis, chronic pain syndrome, autonomic dysreflexia, neurogenic bladder (has a suprapubic catheter), seizures, homocystinemia, protein s deficiency, hiatal hernia, gastric reflux disease, gastric leiomyoma, cva x2, degenerative joint disease, mitral valve prolapse, insomnia, and hypercoagulable state.The indication for the filter placement was left leg deep vein thrombosis (dvt) and inability to anticoagulate due to drop in hematocrit and hemoglobin.The filter was deployed in the infrarenal ivc.Filter placement was immediately followed by placement of a peripherally inserted central catheter line via the right basilic vein.Nine days post implant, a magnetic resonance imaging (mri) of the abdomen was performed to rule out adenoma, no lesions were observed.Twelve days post implant a computed tomography (ct) scan of the abdomen and pelvis was performed due to a history of anemia, swollen leg and dvt.Results of the scan noted no pelvic masses or adenopathy, diffuse swelling of the left lower extremity and surgically absent uterus.The ivc filter is in place.Thirteen years and one month post implant, a ct scan of the abdomen was performed.The original radiology results were not provided.The images were submitted to additional review approximately two years after the scan was performed and noted ivc stenosis and 3mm mesenteric perforation.The product remains implanted and therefore not available 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 trapease 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 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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported perforation and stenosis could not be confirmed or further clarified.Shortness of breath, migraines, nausea and fatigue do not represent a device malfunction and may be related to underlying patient specific issues of comorbidities.There is nothing to suggest that the reported event is related to the design and/or 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: TRAPEASE PVCF BRACH 90CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12264525
• Report Number: 1016427-2021-05220
• Device Sequence Number: 14763592
• Product Code: DTK
• UDI-Device Identifier: 20705032009475
• UDI-Public: 20705032009475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2008
• Device Model Number: 466P306BU
• Device Catalogue Number: 466P306BU
• Device Lot Number: R1205487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White