MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220B

Device Problems Failure to Align (2522); Migration (4003)

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

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement was not reported.The filter subsequently malfunctioned and caused injury, damage to the patient, including but not limited to additional deep vein thrombosis (dvt) post filter placement, and 19-degree tilt of the filter.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.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.Blood clots, dvt 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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including but not limited to additional deep vein thrombosis (dvt), status post filter, and 19-degree tilt of the filter.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury, damage to the patient, including but not limited to additional deep vein thrombosis (dvt), status post filter, and 19-degree tilting of the filter.Per the medical records, the patient was symptomatic for back pain and was status post anterior and posterior t10-s1 laminectomy about a week prior to being admitted to the emergency department (ed).The patient had been at a rehab facility, where lower leg edema (lle) was noted, and a left leg venous doppler confirmed extensive left lower extremity deep venous thrombosis (dvt).A large left pelvic hematoma was also noted possibly related to previous back surgery.Since the patient had a recent surgery and could not take anticoagulants, placement of the inferior vena cava (ivc) filter was recommended.The patient underwent inferior vena cava (ivc) filter placement via right groin approach.The right common femoral vein was accessed utilizing a single wall puncture needle; a wire was introduced and the needle advanced into the inferior vena cava.An initial contrast injection was performed to visualize the ivc as well as the inflow to the renal veins.An optease ivc filter was then deployed beneath the renal veins.The patient tolerated the procedure well.A follow-up computerized tomography (ct) scan performed demonstrated the ivc filter was malposition above the renal veins the ivc filter was noted with the inferior margin just at the level of the renal veins.Then, using ultrasound guided access of the right common femoral vein and catheterization of the inferior vena cava, the filter was successfully repositioned to below the renal veins without complications.The patient tolerated the procedure well.Approximately four months after the filter was implanted, the patient was diagnosed with tension headache and results from a ct scan were negative for acute processes and a sinus inflammation was reported.Seven months after the filter was implanted the patient was advised that the risk of leaving the filter in was less than the risk of removal.It was decided to keep the filter in place.Approximately two years and three months post implantation, the patient was admitted for back pain and inability to walk.A leak of cerebral spinal fluid (csf) at l2 was diagnosed and treated with bed rest and rehab.During this admission, hypertension was also diagnosed.The patient had presented with shortness of breath and weakness/paralysis.A ct scan revealed no pulmonary embolism and a doppler ultrasound (u/s) confirmed no dvt in the upper limbs at that time.Dvt was noted in the left leg.Approximately five years after the filter was implanted, the patient underwent a ct scan indicated for filter evaluation.The ct findings revealed the filter is tilted and located approximately 2cm below the renal vein.No stenosis, perforation or fracture was noted.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately four years and two months after the filter implantation.The patient reports tilting of the filter, blood clots, clotting and or occlusion of the ivc, and further experienced anxiety related to the filter.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the indication was dvt secondary to immobility from anterior and posterior t10-s1 laminectomy one week prior to admission.Doppler confirmed extensive left lower extremity deep venous thrombosis (dvt).A large left pelvic hematoma was also noted and was possibly related to previous back surgery.An initial contrast injection was performed to visualize the ivc as well as the inflow to the renal veins.An optease ivc filter was then deployed beneath the renal veins.The patient tolerated the procedure well.A follow-up ct scan demonstrated the ivc filter was migrated to above the renal veins with the inferior margin just at the level of the renal veins.The filter was successfully repositioned below the renal veins without complications.The patient tolerated the procedure well.The filter subsequently malfunctioned including but not limited to deep vein thrombosis (dvt) post filter, and filter tilt.Approximately four months post implant, the patient had a tension headache and a ct scan confirmed there were no acute processes and a sinus inflammation was diagnosed.Seven months after implant, the patient was advised that the risk of leaving the filter in was less than the risk of removal.It was decided to keep the filter in place.Approximately two years and three months post implant, the patient had back pain and inability to walk.A cerebral spinal fluid (csf) leak at l2 was diagnosed.During this admission, hypertension was also diagnosed.The patient had presented with shortness of breath and weakness/paralysis.A ct scan revealed no pulmonary embolism and a doppler ultrasound (u/s) confirmed no dvt in the upper limbs at that time.Dvt was noted in the left leg.Approximately five years post implant, a ct revealed the filter was tilted and located approximately 2cm below the renal vein.No stenosis, perforation or fracture was noted.Per in the patient profile form (ppf), the patient reports tilting of the filter, blood clots, clotting and or occlusion of the ivc, and anxiety related to the filter.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 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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.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.Anxiety and shortness of breath 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: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10457375
• MDR Text Key: 204538649
• Report Number: 1016427-2020-04316
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 466F220B
• Device Lot Number: 15999205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 19G PUNCTURE NEEDLE; UNK 6F CATHETER; UNK BENTSON WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 114