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

Catalog Number 4XXXXXX

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Injury (2348); Disability (2371)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.The exact implant date was not provided.The device was implanted sometime in 2009.Occupation: other, litigation paralegal.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a unknown cordis vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter migration.A scan noted that the filter had migrated from its original position.The report also states that the patient is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability and other losses, not limited to the apprehension and risk associated with retaining a defective device inside one's body.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1 and h2.Event: as reported, the patient underwent placement of an unknown cordis inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter migration.A scan noted that the filter had migrated from its original position.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 cordis 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.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 include 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.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: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 7894338
• MDR Text Key: 120894365
• Report Number: 9616099-2018-02401
• Device Sequence Number: 0
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4XXXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other