MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the legal brief, an unspecified period of time after an optease vena cava filter was implanted, the filter subsequently malfunctioned and caused injury, damage, including, but not limited to: blood clots, clotting, and/or occlusion of the ivc.

Manufacturer Narrative

As reported, after placement of an optease inferior vena cava (ivc) filter, the filter subsequently malfunctioned and caused injury, damage, including, but not limited to: blood clots, clotting, and/or occlusion of the ivc.Per the medical records, the filter was placed due to acute on chronic widespread deep venous thrombosis (dvt) and a recent pulmonary embolism (pe).The patient also has a history of tobacco use, hypertension, chronic back pain and intermittent headaches.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), the device is unable to be retrieved and the patient has severe pain and venous stasis ulcers.There have been no documented attempts to retrieve the filter.The patient is reported to experience severe pain as a result of a severe clot completely occluding the ivc filter.The patient¿s veins show acute chronic widespread deep venous thrombosis resulting in inflammation of bilateral lower extremities and ankle swelling/peripheral edema in addition to venous stasis ulcers and a dilated abdominal vein.The patient is also reported to experience mental anguish.Twenty days after implant, the patient was admitted through the er with complaints of lower extremity edema and pain.A duplex ultrasound was performed and showed clot progression now extending from the ankle up to the ivc filter, but not above the filter.The patient was admitted for anticoagulation.The patient was discharged five days later with a month supply of coumadin and desyrel (antidepressant).Approximately 7 years later, a computed tomography angiogram of the chest was performed for complaints of chest pain.Results indicated that there was no pulmonary embolism, acute infiltrates, thoracic aortic aneurysm or dissection.Approximately one year later, the patient presented to the emergency room with complaints of chest pain.The patient was discharged on the same day with a diagnosis of nonspecific chest pain.An x-ray of the kidneys, ureters and bladder was performed to evaluate the ivc filter.Findings indicated that there was no acute abdominal process, the ivc filter is in the expected location slightly to the right of midline.One month later, the patient presented to the emergency room requesting refills for hydrocodone.The patient reportedly suffers from chronic leg pain associated with stasis ulcers.The patient was provided pain medication and discharged the same day.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 optease 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, chronic pain, chest pain, peripheral swelling, inflammation, ulcers on the extremities, vein distension and depression 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.

Manufacturer Narrative

Additional information provided on the patient profile form (ppf)indicated that the patient alleges blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), the device is unable to be retrieved and the patient has severe pain and venous stasis ulcers.The patient became aware of the events approximately six years post implant.There have been no documented attempts to retrieve the filter.The patient is reported to experience severe pain as a result of a severe clot completely occluding the ivc filter.The patient¿s veins show acute chronic widespread deep venous thrombosis resulting in inflammation of bilateral lower extremities and ankle swelling/peripheral edema in addition to venous stasis ulcers and a dilated abdominal vein.The patient is also reported to experience mental anguish due to the fear of additional injuries related to the filter.Information contained in the medical records indicated that the filter was placed due to acute on chronic widespread deep venous thrombosis (dvt) and a recent pulmonary embolism (pe).The patient also has a history of tobacco use, hypertension, chronic back pain and intermittent headaches.Twenty days later, the patient was admitted through the emergency department with complaints of lower extremity edema and pain.The patient had phoned the physician a few days prior requesting pain medications.A duplex ultrasound was performed and showed clot progression now extending from the ankle clear up to the ivc filter, but not above the filter.The patient was admitted for anticoagulation.The patient was discharged five days later with a month supply of coumadin and desyrel (antidepressant) and instructions on where to go to receive free medical care and medications.Approximately 7 years later, a computed tomography angiogram of the chest was performed for complaints of chest pain.Results indicated that there was no pulmonary embolism, acute infiltrates, thoracic aortic aneurysm or dissection.Approximately one year later, the patient presented to the emergency room with complaints of chest pain.The patient was discharged on the same day with a diagnosis of nonspecific chest pain.An x-ray of the kidneys, ureters and bladder was performed to evaluate the ivc filter.Findings indicated that there was no acute abdominal process, the ivc filter is in the expected location slightly to the right of midline.One month later, the patient presented to the emergency room requesting refills for hydrocodone.The patient reportedly suffers from chronic leg pain associated with stasis ulcers.The patient was provided pain medication and discharged the same day.Updates made to section b2.Additional patient codes are as follows: pain (1994), chest pain (1776), inflammation (1931), depression (2361), edema (1820) and ulcers (2326).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information received per the patient profile form (ppf) states that the patient was diagnosed with chronic embolism and thrombosis seven years and four months after the index procedure.As reported, the patient had implant of an optease inferior vena cava (ivc) filter.Per the medical records, the indication for the filter was acute on chronic widespread deep venous thrombosis (dvt) and a recent pulmonary embolism (pe).The patient also has a history of tobacco use, hypertension, chronic back pain and intermittent headaches.The filter subsequently malfunctioned and caused injury, damage, including, but not limited to: blood clots, clotting, and/or occlusion of the ivc.Additional information provided on the patient profile form (ppf)indicated that the patient alleges blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), the device is unable to be retrieved and the patient has severe pain and venous stasis ulcers.The patient is reported to experience severe pain as a result of a severe clot completely occluding the ivc filter.The patient¿s veins show acute chronic widespread deep venous thrombosis resulting in inflammation of bilateral lower extremities and ankle swelling/peripheral edema in addition to venous stasis ulcers and a dilated abdominal vein.The patient is also reported to experience mental anguish and fear.Per the medical records, twenty days after implant, the patient was admitted with complaints of lower extremity edema and pain.A duplex ultrasound was performed and showed clot progression now extending from the ankle clear up to the ivc filter, but not above the filter.The patient was admitted for anticoagulation.Approximately 7 years later, a ct angiogram of the chest was performed for complaints of chest pain.Results indicated that there was no pulmonary embolism, acute infiltrates, thoracic aortic aneurysm or dissection.Approximately one year later, the patient presented to the emergency room with complaints of chest pain.The patient was discharged on the same day with a diagnosis of nonspecific chest pain.An x-ray of the kidneys, ureters and bladder was performed to evaluate the ivc filter.Findings indicated that there was no acute abdominal process, the ivc filter is in the expected location slightly to the right of midline.One month later, the patient presented to the emergency room requesting refills for hydrocodone.The patient reportedly suffers from chronic leg pain associated with stasis ulcers.The patient was provided pain medication and discharged the same day.Per the patient profile form (ppf), the patient was diagnosed with chronic embolism and thrombosis seven years and four months after the index procedure.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 optease 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, thrombosis, embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Peripheral swelling, inflammation, ulcers of the extremities, chest pain and vein distension do not represent a device malfunction and may be related to underlying patient related issues.Anxiety and depression 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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 8080744
• MDR Text Key: 127539854
• Report Number: 1016427-2018-02269
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR