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

Catalog Number 466FXXXX

Device Problems Occlusion Within Device (1423); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Chest Pain (1776); Swelling (2091)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, ivc filter occlusion, post-implant pulmonary embolism, chest pain, swelling, and possible shifting or migration of the filter.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, and pain and suffering, and other damages.No additional information is available.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 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.Blood clots within the filter does not represent a device malfunction.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency subsequently swelling within lower extremities.Chest pain and post procedure pulmonary embolism does not represent a device malfunction.The legal brief also mentioned migration of the filter.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.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.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/or manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, ivc filter occlusion, post-implant pulmonary embolism, chest pain, swelling, and possible shifting or migration of the filter.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, and pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the patient profile form (ppf), the filter was implanted due to deep vein thrombosis.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, ivc filter occlusion, post-implant pulmonary embolism, chest pain, swelling, and possible shifting or migration of the filter.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, and pain and suffering, and other damages.The ppf indicates the filter is unable to be retrieved although there have been no known recorded retrieval attempts.The patient is reported to have experienced shortness of breath and continues to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 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.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Occlusive thrombosis within the filter and post procedural pulmonary embolism do not represent a device malfunction.Chest pain, shortness of breath, swelling, and 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 6840729
• MDR Text Key: 84619892
• Report Number: 1016427-2017-00574
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2017
• 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
• Distributor Facility Aware Date: 08/21/2017
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR