MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problems Failure to Align (2522); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

This report is a follow up report to mfr number 9616099-2016-00330 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.It was reported that a patient underwent placement of an optease vena cava filter (ivc).The indication for the implant is unknown.The filter was placed via the right internal jugular vein, at the time of placement the ivc was free of thrombus and good wall apposition was noted.According to the information received approximately five and a half months later the patient was diagnosed with blood clots, location not reported.Approximately nine years after implant the patient was diagnosed with bilateral pulmonary embolism (pe).Approximately ten years and four months after implant the patient was notified that the filter had titled was embedded and had perforated and was unable to be retrieved.According to the information received, as a result, the patient suffered, inter alia, bilateral pulmonary emboli and the device cannot be removed.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.According to the patient profile form the patient is experiencing anxiety.The form also indicates that the filter is unable to be retrieved, however there are no documented attempts to retrieve the device.There is currently no additional information available.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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 thrombosis within the filter do not represent a device malfunction.Without the procedural films or post implant images to review the reported, tilt, blood clots, clotting, occlusion of the device, perforation and retrieval difficulty could not be confirmed.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 in the legal brief, the patient had an optease filter implanted on or about (b)(6) 2006.The device subsequently tilted and perforated the vena cava.As a result, the patient suffered, inter alia, bilateral pulmonary emboli and the device cannot be removed.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information received per the patient profile form indicates that the patient has also experienced blood clots/clotting, occlusion of the ivc filter and anxiety related to the device.Also, the patient profile form indicates that the filter is unable to be retrieved although there are no known recorded retrieval attempts.

Manufacturer Narrative

According to the information received in the short form the patient reports migration of the filter other than to heart, tilt, perforation of the struts outside the ivc, and device unable to be retrieved.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Correction data: patient identifier (in confidence).It was reported that a patient underwent placement of an optease vena cava filter (ivc).The information provided indicated that the filter subsequently tilted and perforated the vena cava.As a result, the patient suffered, inter alia, bilateral pulmonary emboli and the device cannot be removed.The following additional information received per the patient profile form indicates that the patient has also experienced blood clots/clotting, occlusion of the inferior vena cava (ivc) filter and anxiety related to the device.Also, the patient profile form indicates that the filter is unable to be retrieved although there are no known recorded retrieval attempts.The indication for the implant is unknown.The filter was placed via the right internal jugular vein, at the time of placement the ivc was free of thrombus and good wall apposition was noted.According to the information received approximately five and a half months later the patient was diagnosed with blood clots, location not reported.Approximately nine years after implant the patient was diagnosed with bilateral pulmonary embolism (pe).Approximately ten years and four months after implant the patient was notified that the filter had titled was embedded and had perforated and was unable to be retrieved, however there are no documented attempts to retrieve the device.There is currently no additional information available for review.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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting and thrombosis within the filter do not represent a device malfunction.The ivc is not indicated for use in the prevention of recurrent dvt.There are possible patient and pharmacological factors that may have contributed to the reported event.Without procedural films for review, the filter tilt, migration and perforation reported could not be confirmed.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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.The timing and mechanism of the tilt, migration and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.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 includes 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 the procedural films or post implant images to review the reported recurrent pe, tilt, migration, perforation and thrombus within the device could not be confirmed or further clarified.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7125864
• MDR Text Key: 95181790
• Report Number: 1016427-2017-00882
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K023116
• 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: 07/10/2018

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 Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 05/31/2018; 07/07/2018
• Supplement Dates FDA Received: 06/29/2018; 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 57 YR