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

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001)

Event Date 12/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that the contact is not a medical professional but a more accurate choice is not available.Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, the patient underwent optease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury, damage, including, but not limited to, tilt and perforation of the filter.As a direct and proximate result of this malfunction, 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.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 inferior vena cava (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 and perforation 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.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.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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 in the legal brief, the patient was treated with an optease vena cava filter which subsequently malfunctioned and caused injury, damage, including, but not limited to tilt and perforation of the ivc filter.As a direct and proximate result of this malfunction, 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b6, b7, d1, d4, d11, g3, g4, g7, h1, h2, h4 and h6.Section b5: additional information received per the medical records indicate that the patient has a history of lower extremity deep vein thrombosis.The filter was deployed via the patient's right internal jugular vein.It was placed into the infrarenal area of the inferior vena cava (ivc).  additional information received per the patient profile form (ppf) states that a computed tomography (ct) scan performed for evaluation revealed tilting of the filter and perforation.The patient also experienced perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient discovered that her filter suffered from blood clots, clotting and/or occlusion of the ivc approximately six years and nine months after the index procedure.These events have caused the patient to experience emotional distress, mental anguish, anxiety and stress.As reported, the patient was treated with an optease inferior vena cava (ivc) filter.Per the medical record, history includes lower extremity deep vein thrombosis.The filter was deployed into the infrarenal area of the inferior vena cava (ivc).The filter subsequently malfunctioned and caused injury, damage, including, but not limited to tilt and perforation of the ivc filter.Per the patient profile form (ppf), a ct scan revealed tilting of the filter and perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient further reports emotional distress, mental anguish, anxiety and stress.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.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.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.

• 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: 8651232
• MDR Text Key: 146414907
• Report Number: 1016427-2019-02916
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1207124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5 AND 9 FRENCH CATHETER; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR