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

Model Number 466P306X

Device Problems Fracture (1260); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Cellulitis (1768); Hemorrhage/Bleeding (1888); Occlusion (1984); Pain (1994); Respiratory Distress (2045); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)

Event Date 01/24/2013

Event Type  Injury  

Manufacturer Narrative

As reported by the legal team, the plaintiff underwent placement of defendant 'trapease, vena cava filer on or about (b)(6) 2009'.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including,' but not limited to, hemorrhage, internal bleeding, severe pain, recurrent blood clots; recurrent dvts, and respiratory distress.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries a damage, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  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.  without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.The trapease 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.As per the instructions for use (ifu), implantation of the trapease filter is contraindicated in patients with uncontrolled infectious disease.There are possible patient and pharmacological factors that may have contributed to the reported events of severe and constant chest pains and shortness of breath.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Pain, blood clots, respiratory distress, or thrombosis does not represent a device malfunction.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 by the legal team, the plaintiff  underwent placement of defendant 'trapease, vena cava filer on or about (b)(6) 2009'.The filter subsequently malfunctioned and.Caused injury and damages to the plaintiff, including,' but not limited to, hemorrhage, internal bleeding, severe pain, recurrent blood clots; recurrent dvts, and respiratory distress.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries a damage, and required extensive medical care and treatment as a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events three years and ten months post implantation and reports to be suffering from anxiety, to have had pulmonary embolism (pe) and that the device is unable to be retrieved, however, there have been no known attempts made to remove the filter.According to the information received in the medical records, the patient has a history of lumbar laminectomy, back pain, dvt of lower extremities, hypertension, hyperlipidemia, benign prostatic hyperplasia (bph), and coronary artery disease.The ivc filter was placed via the right common femoral vein.The filter was placed after lower extremity dvts complicated an unknown surgery.Sometime post implantation of ivc filter, the patient had a thrombosed ivc filter and underwent mechanical and chemical thrombolysis to reestablish flow from the lower extremities through the inferior vena cava filter and including the iliac veins bilaterally.Three years and ten months post implantation, the patient underwent a cardiac catheterization, after which the patient kept experiencing chronic pain at the cath site and saw drainage.Three years and eleven months post implantation, the patient presented with numbness and weakness of the left upper extremity and was diagnosed with acute cerebrovascular accident (cva), most likely embolic in origin and left hemiparesis.A computerized tomography (ct) of the brain, documented right frontoparietal ischemia.During this visit, the patient received a workup for hypercoagulable state and was diagnosed with factor v leiden mutation which increases the risk for thrombosis, acute cellulitis of the right groin and atypical chest pain.The patient had undergone a catheterization, in which the patient experienced pain and nausea.Afterwards, the patient was noted to have dvt.The patient was discharged on lovenox.Three weeks prior to this event, the patient had presented to the hospital with chest pain.Approximately five years post implantation of the ivc filter the patient was found to have collateralized circulation however the filter was patent at that time.Approximately on or about five years and seven months post implantation of the ivc filter, the patient was admitted for worsening dyspnea, chest discomfort, and lower extremity edema.The patient was found to have a dvt in the right lower extremity.Nine and ten months later, the patient presented twice more with lower extremity edema and shortness of breath and both times was diagnosed with dvt and pe.Less than a month later the patient presented once again with bilateral leg swelling, chest pain, and difficulty breathing.A duplex scan revealed persistent thrombus in the entire right femoral vein and popliteal vein.Occlusion of proximal and mid portion of the right femoral vein was also identified.About three months after, the patient had presented with bleeding cuticles and noting bleeding gums when brushing the teeth and a supratherapeutic inr.About ten months later, the patient presented with peticheal rash and had a nosebleed episode while on xarelto and was diagnosed with acute dvts.The patient was restarted on coumadin due to failing anticoagulation therapy with eliquis and lovenox and being unable to maintain inr.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of lumbar laminectomy, back pain, dvt of lower extremities, hypertension, hyperlipidemia, benign prostatic hyperplasia (bph), and coronary artery disease.The ivc filter was placed via the right common femoral vein.The filter was placed after lower extremity dvts complicated an unknown surgery.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, hemorrhage, internal bleeding, severe pain, recurrent blood clots, recurrent deep vein thrombosis (dvt), and respiratory distress.Post implantation of ivc filter, the patient had thrombosis ivc filter and underwent mechanical and chemical thrombolysis to reestablish flow from the lower extremities through the inferior vena cava filter and including the iliac veins bilaterally.Approximately 4 years post implantation, the patient presented with numbness and weakness of the left upper extremity and was diagnosed with acute cerebrovascular accident (cva), most likely embolic in origin and left hemiparesis.During this visit, the patient was diagnosed with factor v leiden mutation, acute cellulitis of the right groin and atypical chest pain.The patient had undergone a catheterization, in which the patient experienced pain and nausea.Afterwards, the patient was noted to have dvt.The patient was discharged on lovenox.The patient had undergone a catheterization, in which the patient experienced pain and nausea.Afterwards, the patient was noted to have dvt.The patient was discharged on lovenox.Approximately five years post implantation, the patient was found to have collateralized circulation and the filter was patent at that time.Approximately 6 years post implantation of the ivc filter, the patient was admitted for worsening dyspnea, chest discomfort, and lower extremity edema.The patient was found to have a dvt in the right lower extremity.Approximately 1 year later, the patient presented twice more with lower extremity edema and shortness of breath and both times was diagnosed with dvt and pe.Less than a month later the patient presented once again with bilateral leg swelling, chest pain, and difficulty breathing.A duplex scan revealed persistent thrombus in the entire right femoral vein and popliteal vein.Occlusion of proximal and mid portion of the right femoral vein was also identified.About three months after, the patient had presented with bleeding cuticles and noting bleeding gums when brushing the teeth and a supratherapeutic inr.About ten months later, the patient presented with peticheal rash and had a nosebleed episode while on xarelto and was diagnosed with acute dvts.The patient was restarted on coumadin due to failing anticoagulation therapy with eliquis and lovenox and being unable to maintain inr.Per the patient profile form (ppf), the patient has anxiety.The filter remains implanted; thus, 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 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.Blood clots, clotting, hypercoagulability, genetic coagulopathy, pulmonary embolism, stroke related to thrombosis and thrombosis within the filter and vasculature do not represent a device malfunction and are most likely related to the underlying patient condition.Internal hemorrhage does not represent a device malfunction and may be related other issues.Chest pain and respiratory distress does not represent a device malfunction and may be related to underlying coagulopathy or cardiovascular disease related issues.Collateral circulation, cellulitis, edema and nausea do not represent a device malfunction and may be related to underlying patient related issues.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

Additional information received per an amended patient profile form (ppf) states that the patient experienced fractured filter, perforation of filter strut(s) outside the inferior vena cava (ivc), filter tilt within ivc, blood clots, clotting, and/or occlusion of the ivc.The form specified that there was a fracture of the posterior limb of prong, the struts are retained in the bowel mesentery and struts abut adjacent organs.The patent continues to experience worry and anxiety related to the filter.The patient became aware of the reported events eleven years and two months after the index procedure.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, d4,e3, e4, g1, g3, g4, g7, h1, h2 and h6.Section e3: occupation: other, senior counsel, litigation.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of lumbar laminectomy, back pain, lower extremity deep vein thrombosis (dvt), hypertension, hyperlipidemia, benign prostatic hypertrophy (bph) and coronary artery disease.The filter was implanted via the right common femoral vein.At some point after the filter implantation, the patient developed thrombosis of the filter and underwent mechanical and chemical thrombolysis with re-establishment of flow through the inferior vena cava (ivc).Approximately three years and nine months after the filter implantation, the patient presented with chest pain.Approximately three weeks later, the patient presented with numbness and weakness and paralysis of the left upper extremity and was diagnosed with an acute cerebrovascular accident (cva).The cva was noted to have been embolic in origin.The patient underwent a computerized tomography (ct) scan that revealed right frontoparietal ischemia.During this admission, the patient was noted to be in a hypercoagulable state with factor v lieden mutation.It was noted that this would put the patient at increased risk of thrombosis, acute cellulitis and chest pain.The patient underwent a catheterization procedure and experienced pain and nausea and was later reported to have had a dvt.Approximately five years after the filter implantation, the patient was noted to have collateralized circulation with a patent filter.Approximately seven months later, the patient presented with worsening dyspnea, chest discomfort and lower extremity edema.Diagnostic testing revealed a right lower extremity dvt.Nine months later, the patient developed further dvt and pe and returned again another month later with the same issues.Less than a month later, the patient presented with bilateral leg swelling, chest pain and difficulty breathing.Diagnostic testing revealed persistent thrombus in the entire right femoral vein and popliteal vein with occlusion of the proximal and mid portion of the right femoral vein.Approximately three months later, the patient presented with bleeding cuticles and gums in the setting of the supratherapeutic international normalized ratio (inr).Approximately ten months later, the patient presented with a rash and nosebleed while on xarelto and was again diagnosed with acute dvts.The patient was re-started on coumadin due to failing anticoagulation therapy.More than eleven years after the filter implantation, the patient became aware that the filter had perforated the ivc and was associated with blood clots, clotting and/or occlusion of the ivc.The posterior limb strut of the filter had fractured and that struts were retained in the bowel mesentery and abutting adjacent organs.The patient further reported having experienced hemorrhage, internal bleeding, severe pain, pulmonary embolism (pe), mental anguish, worry and anxiety associated with the filter.In addition, the patient indicated that the filter could not be retrieved; though attempts to retrieve it were not documented.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 trapease vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc 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.Without images or procedural films for review, the reported filter tilt, fracture and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported chest pain, cellulitis, edema, nausea, cva and respiratory distress experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Blood loss is a known potential adverse event associated to the filter device and may be related to the reported perforation.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.It does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 33152 ; EI 33152
• MDR Report Key: 6670618
• MDR Text Key: 78492821
• Report Number: 1016427-2017-00404
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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: 466P306AU
• Device Lot Number: R0808407
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/14/2017
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 57 YR
• Patient Weight: 82