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

CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522); Migration (4003)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135); Thromboembolism (2654)

Event Date 01/08/2013

Event Type Injury

Manufacturer Narrative

Concomitant medical products: cordis 6fr optease sheath 55cm and cordis 6fr sheath 68cm via the right groin.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Correction: d4 - during the product history review, the lot number provided was found to be invalid.Lot number and udi are currently unknown.Additional information: complaint conclusion - as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of pulmonary embolism (pe), chronic lung disease and lap band placement with subsequent removal approximately one month later.In addition, the patient had undergone placement of a previous optease retrievable vena cava filter with successful percutaneous removal approximately one month later.The indication for the second filter placement was reported to be as prophylaxis prior to gastric bypass surgery.Approximately four months later, a second optease retrievable vena cava filter was implanted via the right femoral vein.Approximately six years after the filter implantation, the patient became aware that the filter that tilted, and become embedded and that filter strut(s) had perforated outside the wall of the inferior vena cava (ivc).The filter was also associated with blood clots.In addition, the patient underwent a complex percutaneous removal of the filter; with fracture of the filter and retention of fractured fragment(s) within the patient.The patient further reported having experienced mental anguish and anxiety associated with the filter.The product was not returned for analysis and a valid sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc 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.Without images or procedural films for review, the reported filter tilt, fracture, ivc perforation and retrieval difficulty events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.The reported details indicate that retrieval was attempted approximately six years after implantation.Retrieval of the optease retrievable vena cava filter is indicated up to 23 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 twelve days.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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 thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to blood clots, ivc perforation, complex removal, filter fracture, tilt, embedment.Per the medical records, the patient was implanted with two optease filters (device #1 and device #2) at different times.The initial optease filter (device #1) was indicated prior to gastric bypass surgery.The filter was removed percutaneously approximately twenty-eight days post implantation.Procedural details were not provided.Three months after removal of filter device #1, the patient had implant of filter (device #2), indicated for gastric bypass surgery.The patient was reported to have a history of chronic lung disease, previous pulmonary embolism and lap band with removal.The filter was deployed in the inferior vena cava without complications.Approximately six years after implantation, filter device # 2 was removed percutaneously.Procedural details were not provided.Per the patient profile form (ppf), the patient reports fracture, perforation of the filter strut(s) outside the inferior vena cava, migration, thrombosis / embolism, tilting and filter embedded in the wall of the ivc.The patient also reports anxiety.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.The instructions for use (ifu) states filter fracture with perforation 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.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.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.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.Blood clots, embolus and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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

Manufacturer Narrative

As reported, the patient underwent placement of two optease retrievable vena cava filters at different times.The patient is reported to have had a history of chronic lung disease and previous pulmonary embolism (pe).The initial filter was implanted prior to gastric bypass surgery (lap band removal).The filter was successfully implanted via the right groin.This filter was retrieved percutaneously approximately twenty-eight days after the implant.Details regarding this filter¿s retrieval were not reported.Three months later, the patient was implanted with a second optease retrievable vena cava filter.This filter was implanted prior to gastric bypass surgery.This second filter was implanted via the right femoral vein in the inferior vena cava (ivc) without complications.Approximately six years after the filter implantation, the patient became aware that the filter had tilted, fractured and migrated.The patient developed blood clots, thrombosis and/or embolism.Filter strut(s) had perforated outside the ivc and become embedded in it.The patient is reported to have undergone a complex percutaneous filter retrieval with the use of an excimer laser sheath dissector, tri-lobed snare and balloon angioplasty.The filter was successfully removed with one strut fragment retained within the wall of the ivc.The patient is reported to have tolerated the procedure well and without immediate complications.The patient further reported having experienced mental anguish, emotional distress, stress and anxiety associated with 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 retrievable vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in ivc 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.Without images or procedural films for review, the reported filter tilt, migration, fracture, ivc perforation and retrieval difficulty events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.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 ivc 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.The timing and mechanism of the fracture has not been reported at this time.The ifu states that 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.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.The reported details indicate that retrieval was attempted approximately three years after implantation.Retrieval of the optease retrievable vena cava filter is indicated up to 23 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 twelve days.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: blood clots, inferior vena cava (ivc) perforation, complex removal, filter fracture, tilt, embedment.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.According to the medical records provided, the patient was implanted with two different optease filters (device #1 and device #2) at different times.Per the implant records, the patient underwent successful insertion of a cordis optease inferior vena cava filter (device #1) via the right groin, which was indicated for gastric bypass surgery.The filter was removed percutaneously approximately twenty-eight days post implantation.Procedural details were not provided.Per the implant records, three months after removal of filter device #1, the patient underwent a venacavagram and insertion of another ivc filter (device #2), indicated for gastric bypass surgery.The patient was reported to have a history of chronic lung disease, previous pulmonary embolism and lap band with removal.A patent inferior vena cava without any anomalies was identified by venogram findings.A sheath was inserted using the seldinger technique into the right femoral vein followed by successful placement of a cordis optease filter in the inferior vena cava without complications.The surgeon recommended removal of the filter in about 4-6 weeks as soon the patient could be on anticoagulation post operatively.Approximately six years after implantation, filter device # 2 was removed percutaneously.Procedural details were not provided.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately six years post implantation.The patient reports fracture, perforation of the filter strut(s) outside the inferior vena cava, tilting and filter embedded in the wall of the ivc.The patient also reports suffering from anxiety regarding the portion of the ivc filter that broke during the removal procedure and was not able to be retrieved.According to the information received in the updated legal brief, the patient additionally reports filter migration and thrombosis/embolism.The patient was reported to have a history of embedded and fractured optease filter placed six years earlier and presented for complex removal given no current indication for ongoing ivc filtration.An inferior venacavagram showed no evidence of stenosis or filling defects.An optease filter was present with its hook tilted and embedded in the left common iliac vein near the confluence of the ivc.A fractured side rail was noted along the left wall of the ivc.The other side rails of the filter appeared to be penetrating beyond the wall of the ivc.The patient underwent a successful complex removal of a fractured, penetrating, and embedded optease ivc filter using wire loop technique and excimer laser; successful retrieval of a fractured filter strut using a tri-lobed snare; and a small post retrieval caval pseudoaneurysm was successfully treated with balloon tamponade.The patient tolerated the procedure well without immediate complication.According to the information received in the updated legal brief, the patient additionally reports blood clots, clotting, and/or occlusion of the ivc.

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Brand Name

OPTEASE RETRIEVAL FILTER

Type of Device

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Manufacturer (Section D)

CORDIS CASHEL

cahir road

cashel, co. tipperary

MDR Report Key

9488163

MDR Text Key

172195834

Report Number

1016427-2019-03692

Device Sequence Number

Product Code

DTK

Combination Product (y/n)

PMA/PMN Number

K034050

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

12/18/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Expiration Date

10/31/2015

Device Model Number

466F220A

Device Catalogue Number

466F220A

Device Lot Number

15755303

Was Device Available for Evaluation?

Date Manufacturer Received

09/24/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Life Threatening;

Patient Age

45 YR

Patient Weight

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

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