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Model Number 466P306X |
Device Problems
Fracture (1260); Difficult to Remove (1528)
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Patient Problems
Coagulation Disorder (1779); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)
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Event Date 07/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number is unknown; if received it will be provided.Complaint conclusion: 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 pain, filter fracture requiring a complicated removal procedure, occluded inferior vena cava (ivc) and right common iliac requiring caval stenting and extensive clot removal, caval thrombectomy, and anxiety.The indication for the filter placement, procedural details and medical history have not been provided and there is 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.The trapease ivc filter is intended for permanent placement.Blood clots and occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Thrombectomy is typically performed to re-establish blood flow, prevent further clot formation and embolism of the clot.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without procedural films or post implant imaging and the limited information available for review, the reported events could not be confirmed or further clarified.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.Given the limited information currently available for review, 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.
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Event Description
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As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: pain and suffering physical injury; filter fracture requiring a complicated removal procedure, occluded ivc and right common iliac requiring caval stenting and extensive clot removal, caval thrombectomy and other post-operative complications; emotional and psychological trauma; anxiety; diminished capacity; hedonic damages; loss of consortium; lost wages; loss of earning capacity; disability; disfigurement; scarring; past and future medical expenses; and any other damages the patient may be entitled to in law or equity.
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Manufacturer Narrative
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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 pain, filter fracture requiring a complicated removal procedure, occluded inferior vena cava (ivc) and right common iliac requiring caval stenting and extensive clot removal, caval thrombectomy, and anxiety.The patient reports becoming aware of filter fracture, perforation of strut(s) outside the inferior vena cava (ivc), perforation of strut(s)into organs, blood clots, clotting, and/or occlusion of the ivc, and filter fracture leading to occlusion resulting in tearing of the ivc during removal with post-op bleeding and stenosis, approximately seven years and five months post implant.The patient underwent a percutaneous removal of the filter approximately eight years post implant.The patient also reports stress, anxiety, insomnia and weight loss related to the filter.The patient reported that they were told they suffer from post-traumatic stress disorder as a result of the filter fracture and complicated removal surgery.Per the implant records the patient was reported to have a history of deep vein thrombosis (dvt) and contraindication to anticoagulation.An angiography and filter placement were ordered for bilateral lower extremity dvt with gastrointestinal (gi) bleeding.The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc.There were no immediate complications and the patient tolerated the procedure without difficulty.Approximately seven years and five months post implant, the patient underwent an abdominal computerized tomography (ct) scan to evaluate the filter.The ct findings reported a birdcage type ivc filter.The left and posterior struts appeared bent and/or fracture, and the ivc appeared stenotic below the filter.The patient underwent a complex removal procedure approximately eight years post implant.The removal record noted that the pre-procedure diagnosis was ivc filter fracture and ivc occlusion.The procedure was noted to be difficult requiring laser catheter assistance and angioplasty.Extravasation after angioplasty of occluded infrarenal ivc and right common iliac requiring stenting and extensive clot removal.There was good return of venous outflow from the right common iliac and stented portion of the right common iliac and ivc at the end of the exam.Complete removal of the trapease filter, occluded left common femoral vein.The filter and clots were sent for cytology.The cytology report noted that the filter was grossly distorted in shape with a moderate amount of calcified thrombus material present.The device consisted of six connected struts.During the post-procedure stay the patient was put on therapeutic heparin and experienced a significant drop in hematocrit and hemoglobin.The patient was returned to interventional radiology the following day.A cavogram was performed and noted no thrombus throughout the length of the right common iliac vein and the infrarenal ivc; however, a small area of active extravasation from the ivc was noted at the junction of the 20mm and 12 mm.The issue was treated with deployment of a cuff stent graft.Cavogram and cone beam ct demonstrated no further extravasation, however a large volume retroperitoneal hematoma was visualized.The patient tolerated the procedure well.There were no significant complications and no other complications during the procedure.There is 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.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.The trapease ivc filter is intended for permanent placement.Blood clots and occlusive thrombosis within the filter and/or vasculature and stenosis do not represent a device malfunction.Stenosis is an abnormal narrowing of a vessel.Thrombectomy is typically performed to re-establish blood flow, prevent further clot formation and embolism of the clot.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without procedural films or post implant imaging and the limited information available for review, the reported events could not be confirmed or further clarified.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.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Post-traumatic stress disorder (ptsd) is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event.The most common events leading to the development of ptsd include, combat exposure, childhood physical abuse, sexual violence, physical assault, being threatened with a weapon and having been involved in an accident.Many other traumatic events also can lead to ptsd, such as fire, natural disaster, mugging, robbery, plane crash, torture, kidnapping, life-threatening medical diagnosis, terrorist attack, and other extreme or life-threatening events.Symptoms may include negative thoughts about oneself or others, hopelessness, memory problems, feeling detached from family and friends, a lack of interest in activities once enjoyed, and feeling emotionally numb, to name a few.Ptsd, anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues, with the limited information provided it is not possible to draw a conclusion to the issue and the device.Given the limited information currently available for review, 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.
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Event Description
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As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: pain and suffering physical injury; filter fracture requiring a complicated removal procedure, occluded inferior vena cava (ivc) and right common iliac requiring caval stenting and extensive clot removal, caval thrombectomy and other post-operative complications; emotional and psychological trauma; anxiety; diminished capacity; hedonic damages; loss of consortium; lost wages; loss of earning capacity; disability; disfigurement; scarring; past and future medical expenses and any other damages the patient may be entitled to in law or equity.Per the implant records, the patient was reported to have a history of deep vein thrombosis (dvt) and contraindication to anticoagulation.An angiography and filter placement was ordered for bilateral lower extremity dvt with gastrointestinal (gi) bleeding.The right neck was prepped and draped in the usual sterile fashion.Using ultrasound guidance and a micro puncture set, the right internal jugular vein was cannulated.A wire was advanced without difficulty into the left common iliac vein.An inferior venacavogram performed was normal without evidence of acute thrombus.Subsequently, a trapease filter was advanced into position and was deployed under fluoroscopy in the infrarenal ivc.There were no immediate complications.The patient tolerated the procedure without difficulty and was transferred to the recovery room in stable condition.Approximately seven years and five months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The ct findings reported a birdcage type ivc filter.The left and posterior struts appeared bent and/or fracture, and the ivc appeared stenotic below the filter.Incidental findings included a hiatal hernia, a multifocal patchy infiltrate in the right middle lobe and moderate spondylosis and degenerative disc disease of the thoracolumbar spine.The patient underwent a complex removal procedure approximately eight years after the filter was implanted.The removal record noted that the pre-procedure diagnosis was ivc filter fracture and ivc occlusion.The procedure was noted to be difficult requiring laser catheter assistance and angioplasty.Extravasation after angioplasty of occluded infrarenal ivc and right common iliac requiring stenting and extensive clot removal.There was good return of venous outflow from the right common iliac and stented portion of the right common iliac and ivc at the end of the exam.Complete removal of the trapease filter, occluded left common femoral vein.The filter and clots were sent for cytology.The cytology report noted that the filter was grossly distorted in shape with a moderate amount of calcified thrombus material present.The device consisted of six connected struts.During the post-procedure stay the patient was put on therapeutic heparin and experienced a significant drop in hematocrit and hemoglobin.The patient was returned to interventional radiology the following day.A cavogram was performed and noted no thrombus throughout the length of the right common iliac vein and the infrarenal ivc; however, a small area of active extravasation from the ivc was noted at the junction of the 20mm and 12 mm.The issue was treated with deployment of a cuff stent graft.Cavogram and cone beam ct demonstrated no further extravasation, however a large volume retroperitoneal hematoma was visualized.The patient tolerated the procedure well.There were no significant complications and no other complications during the procedure.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years and five months after the filter implantation.The patient reports perforation of filter struts outside the ivc, perforation of filter struts into organs, blood clots, clotting and or occlusion of the ivc, filter fracture leading to occlusion resulting in tearing of the ivc during removal surgery with post op bleeding leading to inpatient hospitalization; stenosis and lifelong anticoagulation, stress, anxiety and insomnia with nightmares about the filter causing future harm or death.The patient additionally underwent a very difficult and complicated percutaneous removal surgery that resulted in removal of extensive clot/occlusion removal.The patient also suffered post-operative complications due to tearing of ivc wall and bleeding that required stenting and inpatient hospitalization.The patient further asserts to have suffered from insomnia and nightmares, post-traumatic stress disorder (ptsd) as a result of the filter fracture and complicated removal surgery, weight loss, and anxiety related to the filter.
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