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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER 55CM THROMBECTOMY SYSTEMS (DQO)

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CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER 55CM THROMBECTOMY SYSTEMS (DQO) Back to Search Results
Catalog Number 466P306AU
Device Problem Occlusion Within Device (1423)
Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Thrombosis (2100)
Event Date 04/24/2016
Event Type  Death  
Manufacturer Narrative
The product remains implanted and is thus not available for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by a pathologist, approximately 4 years after a trapease ivc filter implantation the patient complained of bilateral leg pain before being taken to the emergency room. The patient assessment in the er noted hypotension and tachycardia. Treatment provided is unknown and the patient was discharged home. The patient collapsed at home the next day and was taken to a regional institution where was pronounced dead. An autopsy was conducted with the following findings: trapease filter was occluded by a very large thrombus believed to be a sudden clot from dvt. The filter was intact, with no strut or barb fractures and well embedded/endothelialized into the vessel wall. The ivc wall was found dissected around the filter, involving the majority of the ivc wall and extending inferiorly. The cause of death is assessed as ivc dissection resulting in retroperitoneal hemorrhage. The filter was intentionally fractured in several locations to perform the biopsy and will therefore not be returned for evaluation. The indication for initial ivc placement was factor v leiden thrombophilia. Hence, the ivc filter was indicated and successfully implanted. The patient's family reported that the night before the patient's death, they took him to the er with complaints of bilateral leg pain. The patient wobbled to sit on the wheel chair in the er.
 
Manufacturer Narrative
Films which could not be read and the autopsy report were received. Autopsy images/pictures reviewed. Unable to confirm vessel dissection caused by ivc filter with the images made available. The autopsy report indicated the following: the decedent is a (b)(6) man with a medical history that includes factor v leiden mutation, deep vein thrombosis (dvt) status post inferior vena cava (ivc) filter placement (2012), cerebral hemorrhage (2012; following anticoagulation therapy for dvt), transient ischemic attacks, hypertension, hyperlipidemia, gastroesophageal reflux disease, ulcers (unspecified), hepatitis (unspecified), low back pain secondary to lumbar stenosis and degenerative disc disease with radiculopathy, and benign prostatic hypertrophy. His oral medications include the following: metoprolol 100mg once daily, losartan 50mg once daily, amlodipine (dose not specified), simvastatin 20 mg once daily, gabapentin 200 mg three times daily, diclofenac 5 mg twice daily, diazepam 5 mg once daily, tamsulosin 0. 4 mg once daily, and three multivitamins. Due to his prior history of cerebral hemorrhage in 2012, he was not on anticoagulation therapy. The decedent presented to (b)(6) hospital emergency department on (b)(6) 2016 for generalized weakness and lightheadedness that improved with sitting; he had taken all of his scheduled medications. As per the decedends family, he was also experiencing severe low back pain and bilateral leg pain, which was worse on the right side. On arrival, he was hypotensive (bp 98/63 mmhg), borderline tachycardic (hr 102 bpm) with an elevated bun (37 mg/dl), creatinine (1. 88 mg/dl), and glucose (214 mg/dl), but had otherwise unremarkable ekg, complete metabolic panel, troponin level, cpk level, and urinalysis. No hemoglobin or hematocrit levels were received with the provided emergency department records. His blood pressure and pulse improved to 112/58 mmhg and 80 bpm respectively after receiving approximately 900 ml of intravenous fluid. On ambulation his blood pressure dropped to 93/64 mmhg, however, his pulse rate remained stable. He was diagnosed with orthostatic hypotension and dehydration. He was advised to hold his next day's dose of blood pressure medication, and discharged home with an appointment with his primary care physician for the following day. As per his family, he continued to have severe, persistent back pain for which he took a single dose of valium 5mg po at approximately 9:30pm that evening. While at home on (b)(6) 2016, he complained of weakness, his legs collapsed from under him, and he progressively lost consciousness. Ems was called and upon arrival, his blood pressure was 60/40 mmhg with agonal breathing. He was transported to (b)(6) hospital emergency department. Blood per rectum was noted. He went into pulseless electrical activity cardiac arrest and despite advanced cardiac life support protocol, he was pronounced dead on (b)(6) 2016. At the request of the family, an autopsy was performed on at (b)(6) hospital on (b)(6) 2016. Autopsy findings were significant for a 40 x 30 x15 em retroperitoneal hematoma, which was centered about the right infra-renal inferior vena cava (ivc) and 1. 1 liters of fresh blood within the peritoneal cavity. The hematoma surrounded the kidneys and extended from the peripancreatic fat, into the mesenteric root, and to the pelvic outlet. An 11 x 2 x 2 em thromboembolus was entrapped in the ivc filter, which caused complete occlusion of the lumen. No obvious fractures or displacement of the ivc filter was noted on radiograph. Further gross and microscopic examination of the thromboembolus, filter, and ivc demonstrated the following: an acute thromboembolus with no evidence of recanalization, endothelialization of the vertical filter struts, an acute organizing ivc dissection located in the venous wall adjacent to the vertical struts of the filter, which communicated (i. E. Ruptured) to the adventitial surface and surrounding retroperitoneal hematoma. In addition to the acute organizing ivc dissection, a single microscopic area of granulation tissue with recanalization was present in the ivc wall, which suggests that a small chronic ivc dissection existed prior to the larger, acute ivc dissection and rupture. There was no other identifiable source of the retroperitoneal hematoma. The presence of a right deep vein thrombosis was evidenced by lack of blood flow on milking of the right iliac vein and a swollen, edematous and purplish right lower extremity. It cannot be determined if the blood clot within the ivc filter originated within the filter (i. E. A purely thrombotic), embolized from the dvt within the right lower extremity (i. E. A purely embolic event), or was a product of the combination of the two. Additional findings at autopsy include mild atherosclerotic cardiovascular disease, diverticula of the descending colon, benign prostatic hypertrophy, and multinodular goiter of the thyroid. Factor v leiden mutation is the most common inherited thrombophilia and most frequently manifests with spontaneous thrombosis within the venous system. Homozygotes and heterozygotes are at a 50-fold and 5-fold lifetime risk of a major thromboembolic event, respectively. Persons with factor v leiden mutation are typically treated with lifetime anticoagulation therapy once diagnosis of the mutation is made. In this case, the decedent was initially treated with anticoagulation therapy when he first presented with a dvt in 2012. However, the complication of minor cerebral hemorrhages necessitated the discontinuation of anticoagulation therapy and required permanent placement of an ivc filter to mitigate the risk of a fatal pulmonary embolus. Ivc thrombosis is a known complication after filter placement which can arise due to thrombogenicity of the device, trapped embolus from a distal site, or proximal extension of a distal dvt. Clinically, ivc thrombosis can present with lower back pain, edema of the lower extremity, phlegmasia cerulea dolens, renal dysfunction, or sciatic pain. Minor bleeding from strut perforation exclusive of the immediate intraoperative period has been reported in the literature; however, massive hemorrhage and/or death have not been previously reported. In general, ivc dissection and/or rupture occurs following penetrating (90%) or blunt force trauma (<10%) or is occasionally caused iatrogenically during endovascular procedures. Isolated infra-renal ivc injury (in the setting of blunt trauma) does not cause immediate exsanguination as the pressure of the intact peritoneum slows the rate of bleed from the low pressure venous system, and such injuries present with hypotension that are initially fluid responsive. In this case, there was endothelialization of the ivc filter struts as expected for a filter placed in (b)(6) 2012 with evidence of a microscopic chronic dissection adjacent to a filter strut of likely little clinical consequence. However, the decedent then suffered an acute and complete ivc thrombosis which may have elevated the pressure within the ivc enough to allow significant expansion of the previously microscopic dissection with eventual rupture into the retroperitoneal space. As reported by a pathologist, approximately 4 years after trapease ivc filter implantation the patient complained of bilateral leg pain before being taken to the emergency room. The patient ¿wobbled to sit on the wheel chair in the e. R. ¿the patient assessment in the er noted hypotension and tachycardia. Treatment provided is unknown; however, the patient was discharged home. The patient collapsed at home the next day and was taken to a regional institution where was pronounced dead. An autopsy was conducted with the following findings: trapease filter was occluded by a very large thrombus believed to be a sudden clot from dvt. The filter was intact, with no strut or barb fractures and well embedded/endothelialized into the vessel wall. The ivc wall was found dissected around the filter, involving the majority of the ivc wall and extending inferiorly. The cause of death is assessed as ivc dissection resulting in retroperitoneal hemorrhage. The filter was intentionally fractured in several locations to perform the biopsy and will therefore not be returned for evaluation. The indication for initial ivc placement was factor v leiden thrombophilia. Hence, the ivc filter was indicated and successfully implanted. As noted, the device was not returned for analysis. Review of lot 15622584 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. Given the information available for review, the reported events could not be confirmed and the exact cause could not be determined. 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. Deep vein thrombus, peripheral artery dissection, retroperitoneal hemorrhage, hypotension and tachycardia do not represent a device malfunction. The instructions for use (ifu) note perforation of the vessel wall and intimal tear as potential complications of vena cava filters. Given the information available for review, there is no indication of a design or manufacturing related cause for the reported event; therefore, no corrective action will be taken at this time.
 
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Brand NameTRAPEASE PERMANENT VENA CAVA FILTER 55CM
Type of DeviceTHROMBECTOMY SYSTEMS (DQO)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5662650
MDR Text Key45404364
Report Number9616099-2016-00248
Device Sequence Number0
Product Code DTK
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2015
Device Catalogue Number466P306AU
Device Lot Number15622584
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 Received05/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2016 Patient Sequence Number: 1
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