MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UNKFILTER

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); Pain (1994); Perforation (2001); Swelling (2091); No Code Available (3191)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of either an optease or trapease vena cava filter.Approximately fourteen years post placement the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots, clotting and occlusion of the inferior vena cava (ivc) and approximately three struts were significant perforation the inferior vena cava (ivc) and approximately two struts has fractures.As a direct and proximate result of these malfunction, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require 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.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease and trapease filters are 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/clot from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots and ivc occlusion do not represent a device malfunction.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter fracture and ivc perforation could not be confirmed.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters and recognizes vessel injury as a potential complication.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.However, given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 either defendants¿ optease or trapease vena cava filter.  approximately fourteen years post placement the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots, clotting and occlusion of the inferior vena cava (ivc) and approximately three struts were significant perforation the inferior vena cava (ivc) and approximately two struts has fractures.As a direct and proximate result of these malfunction, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require 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.As reported, the patient underwent placement of either an optease or trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.Approximately fourteen years post placement the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to blood clots, clotting and occlusion of the inferior vena cava (ivc) and approximately three struts significant perforating the inferior vena cava (ivc) and approximately two struts has fractures.As a direct and proximate result of these malfunction, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require 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 additional information received in the patient profile form (ppf), the patient became aware of the reported events fourteen years and eleven months post implantation.The patient reports the filter to be clogged which led to blood flow obstruction in the abdomen and legs.The leg veins were damaged and the veins in the abdomen distended.The patient also reports to be suffering from swelling, lack of sleep, anxiety, pain and ulcers.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.Both the optease and trapease inferior vena cava filters are 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 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 also 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, vein distention, swelling, pain, ulcer and insomnia do not represent device malfunctions 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.

Manufacturer Narrative

According to the additional information received in the patient profile form (ppf), the patient became aware of the reported events fourteen years and eleven months post implantation.The patient reports the filter to be clogged which led to blood flow obstruction in the abdomen and legs.The leg veins were damaged and the veins in the abdomen distended.The patient also reports to be suffering from swelling, lack of sleep, anxiety, pain and ulcers.(b)(4) corrected data: device information in the following sections was updated to reflect an 'unknown' filter as it was unable to be confirmed if the patient had a trapease or an optease filter implanted.Brand name was corrected to 'unknown vena cava filter', catalog number was corrected to 'unkfilter', pma/510(k)number corrected to 'unknown'.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary, ; EI
• MDR Report Key: 6787859
• MDR Text Key: 82478754
• Report Number: 1016427-2017-00523
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR