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

Catalog Number 466F220A

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter tilt and perforation.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 retrievable 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 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.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.

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 damage to the patient, including, but not limited to perforation and tilt.

Manufacturer Narrative

Section b5: additional information received per the medical records indicate that the patient has a history of pulmonary embolism and bariatric surgery.Immediately prior to the index procedure, the patient presented with shortness of breath and chest pressure.The filter was deployed via the patient's right femoral vein.The filter was deployed without difficulty.  additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter and perforation of filter strut(s) outside the inferior vena cava (ivc).The patient became aware of the reported events approximately nine years after the index procedure.The patient continues to experience anxiety and fear.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of recurrent pulmonary embolism (pe) and bariatric surgery.The patient presented to hospital with shortness of breath and chest pressure.The next day, the filter was implanted via the right femoral vein and placed without difficulty.Approximately nine years after the filter implantation, the patient became aware that the filter had tilted, and that strut(s) had perforated outside the inferior vena cava (ivc).The patient further reported having experienced anxiety, mental anguish and fear 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 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 and ivc perforation 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.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.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

Information received per an amended patient profile form (ppf) states that the patient experienced filter fracture within the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events ten years after the index procedure.The patient continues to experience anxiety and worry.

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and tilt.The patient reported becoming aware of filter tilt and perforation approximately nine years post implant.The patient also reported experiencing anxiety.The patient has subsequently reported becoming aware of filter fracture, blood clots, clotting and/or occlusion of the inferior vena cava approximately ten years post implant.According to the implant record the indication for the filter implant was a history of pulmonary embolism, twice and has had bariatric surgery.The patient presented with shortness of breath and chest pressure.The patient first underwent a left heart cardiac catheterization followed immediately with placement of the filter via the right femoral vein.Overall assessment noted essentially normal coronary arteries with a left ventricular ejection fraction of 50% and successful deployment of the ivc filter.There is currently no additional information available for review.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 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.Blood clots, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and vessel characteristics.The instructions for use (ifu) states 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.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 ifu notes vessel damage such as intimal tears and perforation as procedural and long-term 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.Without procedural films or images for review the reported event(s) could not be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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; cashel, co. tipperary; EI
• MDR Report Key: 8836516
• MDR Text Key: 152495699
• Report Number: 1016427-2019-03082
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2020

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: 01/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15104657
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 05/11/2020
• Supplement Dates FDA Received: 08/29/2019; 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 J-WIRE; UNKNOWN 5-FRENCH PIGTAIL CATHETER; UNKNOWN 5-FRENCH RIGHT AND LEFT JUDKINS CATHETERS; UNKNOWN 5-FRENCH SHORT SHEATH; UNKNOWN INTRODUCER SHEATH
• Patient Outcome(s): Life Threatening