|
|
| Model Number 466P306X |
| Device Problem
Fracture (1260)
|
| Patient Problems
Renal Failure (2041); Thrombosis (2100)
|
| Event Date 05/19/2018 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fractured inferior vena cava (ivc) filter; extensive deep vein thrombosis (dvt) requiring thrombectomy with stenting and angioplasty of iliac veins, inferior vena cava (ivc) and into the filter; bilateral extremity swelling; nausea; abdominal pain; distended abdomen; acute kidney injury; bilateral effusions with bibasilar areas of atelectasis.The filter remains implanted; thus, 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.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.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Acute kidney injury as associated to extensive thrombosis of the ivc and filter is a known potential adverse event associated with the use of the ivc filters.Nausea and distended abdomen do 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fractured inferior vena cava (ivc) filter; extensive deep vein thrombosis (dvt) requiring thrombectomy with stenting and angioplasty of iliac veins, inferior vena cava (ivc) and into the filter; bilateral extremity swelling; nausea; abdominal pain; distended abdomen; acute kidney injury; bilateral effusions with bibasilar areas of atelectasis.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
|
| |
|
Event Description
|
|
As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fractured inferior vena cava (ivc) filter; extensive deep vein thrombosis (dvt) requiring thrombectomy with stenting and angioplasty of iliac veins, inferior vena cava (ivc) and into the filter; bilateral extremity swelling; nausea; abdominal pain; distended abdomen; acute kidney injury; bilateral effusions with bibasilar areas of atelectasis.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Per the patient profile form (ppf), the patient reports there has been fracture of the filter, perforation of the filter struts outside of the ivc, tilt and embedment of the filter in the wall of the ivc, blood clots, clotting and/or occlusion of the ivc, chronic caval thrombosis, extensive dvt requiring thrombectomy with stenting and angioplasty of the iliac veins, ivc and into the filter, and the device is unable to be retrieved; however, no retrieval attempt has been documented.The patient further reports acute kidney injury, bilateral effusions with basilar areas of atelectasis, bilateral extremity swelling, nausea, atherosclerotic calcification, abdominal pain and distended abdomen.Further, the patient reports that during the procedure where it was discovered that the filter was fractured, and a filter strut removal was attempted where she lost a lot of blood.Her legs were so swollen they were blue, and she could not walk.The diagnosis was large clots in both legs.Per the medical records, medical history includes diabetes, asthma and hypertension.Surgical history includes appendectomy, hysterectomy, left modified mastectomy approximately 14 years prior to filter implant, breast cancer, acute abscess of the abdomen secondary to metastatic cancer, perforated abscess from necrotizing tumor and small bowel fistula, partial abdominal antrectomy.Prior to ivc filter implant, the patient had, and would continue to have, multiple admissions for gastrointestinal stromal tumor of the abdomen causing bowel perforation and abscess, intraabdominal abscess with i&d, anemia, diabetes, chronic wound management, atelectasis.At the time of implant the patient had a gi tumor with blood loss.Ct scan revealed there are bilateral deep venous thromboses within the common femoral veins.Also, dvt noted in the right external iliac vein.A trapease was deployed in an infrarenal position without reported complications.Approximately two months post implantation, a ct of the abdomen noted an abdominal sarcoma, and an infrarenal trapease filter present.Approximately three months later, the patient was admitted for intraabdominal abscess with gastrointestinal metastatic stromal tumor, vaginal- fistula, possible bladder fistula.Extensive gi resection by exploratory laparotomy with adhesiolysis, enterolysis, sigmoid colectomy and colostomy, with resection of pelvic mass, peritonectomy, resection of small bowel, omentectomy, radial pelvic dissection, cystorrhaphy secondary to metastatic carcinoma, and debulking of tumor from the small bowel and colon, colectomy with decompression of the colon were done.Two weeks later, the patient experienced respiratory failure status post (s/p) gi resection.Two months later, the patient had a mammography s/p left breast ca.Approximately one year post-implant, an ampulla mass was noted on a ct scan.An endoscopic exam done.Five weeks later, the patient was admitted for enterocutaneous fistula with drainage of stool from the abdomen.Ct scan notes the ivc filter was present.Approximately three months later, the patient admitted for gist tumor and anemia, and had a colonoscopy done.Approximately six years post implantation, the patient was admitted for angioedema secondary to lisinopril.Approximately ten years post implantation, scans were done for enlarging goiter of the thyroid suspicious of cancer.Approximately eleven years post implantation, the patient experienced acute dvt and acute small bowel obstruction.Lower extremity dopplers showed extensive occlusive deep vein thrombosis in the right ieg extending from the common femoral all the way into the calf veins with significant swelling.X-ray of the right knee due to right knee pain showed moderate arthritic changes without evidence of infection or edema.Ct of abdomen revealed mild right hydroureteronephrosis, right ureter is mildly dilated to the level of scarring/fibrosis and post-surgical change in the right hemipelvis.Repeat ct scan a week later was performed without contrast and showed no fluid collection suggesting a hematoma, bilateral small effusions with bibasilar atelectasis, left atrial enlargement, old granulomatous disease.Contrast excretion was noted over both kidneys.Ivc filter was noted and venous iliac stents well- expanded.Thrombolysis of the ivc, filter and right lower extremity, bilateral iliac stenting were done.Venogram done revealed improvement of thrombus in the right femoral vein with significant residual thrombus and stenosis in the right common iliac vein.Lesion was successfully treated with mechanical thrombectomy, plasty and stenting.The left iliac venogram demonstrates occlusive thrombus in the left common iliac vein.This lesion was also treated with mechanical thrombectomy and plasty and stenting.Approximately six weeks later, the patient was seen in er for exercise intolerance.E coli uti was diagnosed.Approximately twelve years post implantation, an outside review of medical records and images was done.The findings were as follows; the ivc filter is a trapease ¿permanent¿ filter, deployed in an infrarenal position.The body of the filter is deformed, and the lower portion is tilted posteriorly.The 6 primary struts tent the ivc wall with early perforation suspected medially and anteriorly.One primary strut is fractured and displaced.There are no missing or embolized components identified.Caval thrombosis is suspected.Thrombolysis and endovascular reconstruction were previously done the year before.Also noted is atherosclerotic calcification of the arteries.The conclusion was that filter removal may be recommended but may not be possible without undue risk.
|
| |
|
Manufacturer Narrative
|
|
Additional information was provided and is available in: section a2 (age at the time of event, date of birth) section a4 (patient weight) section a5 (race) section b3 (event date) section b4 (event description) section b7 (relevant medical history) section g4 (date received by the manufacturer) section h6 (evaluation codes) 1779 ¿ coagulopathy/clotting 1984 ¿ inferior vena caval occlusion 1758 - calcification 2697 - valvular stenosis 2135 ¿ ivc perforation 1528 ¿ retrieval difficulty 3191 ¿ appropriate term/code not available for kinked/bent - strut 2522 ¿ tilt complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes diabetes, asthma and hypertension.Surgical history includes appendectomy, hysterectomy, left modified mastectomy approximately 14 years prior to filter implant, breast cancer, acute abscess of the abdomen secondary to metastatic cancer, perforated abscess from necrotizing tumor and small bowel fistula, partial abdominal antrectomy.Prior to ivc filter implant, the patient had, and would continue to have, multiple admissions for gastrointestinal stromal tumor of the abdomen causing bowel perforation and abscess, intraabdominal abscess with i&d, anemia, diabetes, chronic wound management, atelectasis.At the time of implant the patient had a gi tumor with blood loss.Ct scan revealed there are bilateral deep venous thromboses within the common femoral veins.Also, dvt noted in the right external iliac vein.A trapease was deployed in an infrarenal position without reported complications.The filter subsequently fractured inferior vena cava (ivc) filter; there was extensive deep vein thrombosis (dvt) requiring thrombectomy with stenting and angioplasty of iliac veins, inferior vena cava (ivc) and into the filter; bilateral extremity swelling; nausea; abdominal pain; distended abdomen; acute kidney injury; bilateral effusions with bibasilar areas of atelectasis.Per the patient profile form (ppf), the patient reports there has been fracture of the filter, perforation of the filter struts outside of the ivc, tilt and embedment of the filter in the wall of the ivc, blood clots, clotting and/or occlusion of the ivc, chronic caval thrombosis, extensive dvt requiring thrombectomy with stenting and angioplasty of the iliac veins, ivc and into the filter, and the device is unable to be retrieved; however, no retrieval attempt has been documented.The patient further reports acute kidney injury, bilateral effusions with basilar areas of atelectasis, bilateral extremity swelling, nausea, atherosclerotic calcification, abdominal pain and distended abdomen.Further, the patient reports that during the attempted removal procedure, she lost a lot of blood.Her legs are swollen, blue, and she cannot walk, with diagnosis of clots in the legs.Approximately two months post implantation, a ct of the abdomen noted an abdominal sarcoma, and an infrarenal trapease filter present.Approximately three months later, the patient was admitted for intraabdominal abscess with gastrointestinal metastatic stromal tumor, vaginal- fistula, possible bladder fistula.Extensive gi resection by exploratory laparotomy with adhesiolysis, enterolysis, sigmoid colectomy and colostomy, with resection of pelvic mass, peritonectomy, resection of small bowel, omentectomy, radial pelvic dissection, cystorrhaphy secondary to metastatic carcinoma, and debulking of tumor from the small bowel and colon, colectomy with decompression of the colon were done.Two weeks later, the patient experienced respiratory failure status post (s/p) gi resection.Two months later, the patient had a mammography s/p left breast ca.Approximately one year post-implant, an ampulla mass was noted on a ct scan.An endoscopic exam was done.Five weeks later, the patient was admitted for enterocutaneous fistula with drainage of stool from the abdomen.Ct scan notes the ivc filter was present.Approximately three months later, the patient admitted for gist tumor and anemia, and had a colonoscopy done.Approximately six years post implantation, the patient was admitted for angioedema secondary to lisinopril.Approximately ten years post implantation, scans were done for enlarging goiter of the thyroid suspicious of cancer.Approximately eleven years post implantation, the patient experienced acute dvt and acute small bowel obstruction.Lower extremity dopplers showed extensive occlusive deep vein thrombosis in the right ieg extending from the common femoral all the way into the calf veins with significant swelling.X-ray of the right knee due to right knee pain showed moderate arthritic changes without evidence of infection or edema.Ct of abdomen revealed mild right hydroureteronephrosis, right ureter is mildly dilated to the level of scarring/fibrosis and post-surgical change in the right hemipelvis.Repeat ct scan a week later was performed without contrast and showed no fluid collection suggesting a hematoma, bilateral small effusions with bibasilar atelectasis, left atrial enlargement, old granulomatous disease.Contrast excretion was noted over both kidneys.Ivc filter was noted and venous iliac stents well- expanded.Thrombolysis of the ivc, filter and right lower extremity, bilateral iliac stenting were done.Venogram done revealed improvement of thrombus in the right femoral vein with significant residual thrombus and stenosis in the right common iliac vein.Lesion was successfully treated with mechanical thrombectomy, plasty and stenting.The left iliac venogram demonstrates occlusive thrombus in the left common iliac vein.This lesion was also treated with mechanical thrombectomy and plasty and stenting.Approximately six weeks later, the patient was seen in er for exercise intolerance.E coli uti was diagnosed.Approximately twelve years post implantation, an outside review of medical records and images was done.The findings were as follows; the ivc filter is a trapease ¿permanent¿ filter, deployed in an infrarenal position.The body of the filter is deformed, and the lower portion is tilted posteriorly.The 6 primary struts tent the ivc wall with early perforation suspected medially and anteriorly.One primary strut is fractured and displaced.There are no missing or embolized components identified.Caval thrombosis is suspected.Thrombolysis and endovascular reconstruction were previously done the year before.Also noted is atherosclerotic calcification of the arteries.The conclusion was that filter removal may be recommended but may not be possible without undue risk.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.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.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.Stenosis and vascular calcification of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Kink/bent shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.
|
| |
|
Search Alerts/Recalls
|
|
|
