MAUDE Adverse Event Report: CORDIS CASHEL JUGULAR 55CM KIT; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problems Fracture (1260); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Occlusion (1984); Thrombosis (2100)

Event Date 03/05/2016

Event Type  Death  

Manufacturer Narrative

Please note that device reported is an optease or a trapease vena cava filter and for which the catalog and lot numbers are not currently available.The device name was not specified.Patient demographics including medical history were not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, the surviving spouse of the patient brings this case in his individual capacity and as successor in interest of his wife who received an unknown cordis filter on an unspecified date and subsequently died on an unspecified date.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 inferior 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.Without medical records available for review, the clinical cause of the death remains unknown.The legal brief does not mention a malfunction of the filter.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

As reported in the legal brief, the surviving spouse of the patient brings this case in his individual capacity and as successor in interest of his wife who received an unknown cordis filter on an unspecified date and subsequently died on an unspecified date.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient underwent placement of the optease inferior vena cava (ivc) filter due to having a pulmonary embolus, bilateral deep venous thrombosis and a non-traumatic hemorrhage of the cerebral hemisphere.The patient also has a history of altered mental status, and lung cancer metastatic from one side to the other as well as intracerebral metastases.Implantation of the ivc filter was first attempted via the left femoral vein, however, contrast showed that the iliac vein was completely occluded presumably with a clot.An ultrasound then showed the right common femoral vein was clotted.Implantation of the ivc filter was then achieved via the right internal jugular vein.The filter was positioned according to markings on the x-ray ruler and deployed.A repeat hand injection in venogram was performed and demonstrated that the filter was in good position although slightly distal with the lower tip projecting into the right iliac.However, the body of the filter is at or above the iliac bifurcation and this position was considered adequate for protection.According to the information received in the patient profile from (ppf), the patient became aware of the alleged event approximately on or about the same day of ivc filter implantation and reports that the filter had tilted upon deployment.The patient also reports to suffer from emotional distress, mental anguish, anxiety, stress, swelling, blood clots, clotting, occlusion of the ivc and the left iliac vein, and that the filter fractured but unsure of location of retained filter strut within the body.Additionally, the patient reports for the filter to be unable to be retrieved.However, no known attempts for removal of the ivc filter have been made.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient received an optease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the filter due to extensive deep venous thrombosis.Likely has trousseau's syndrome, hypercoagulability related to malignancy.Lung cancer metastatic from one side to the other as well as intracerebral metastases.Some slight intracerebral hemorrhage.Not a candidate for anticoagulation.Implantation of the ivc filter was first attempted via the left femoral vein, however, contrast showed that the iliac vein was completely occluded presumably with a clot.An ultrasound then showed the right common femoral vein was clotted.Implantation of the ivc filter was then achieved via the right internal jugular vein.The filter was positioned according to markings on the x-ray ruler and deployed.A repeat hand injection in venogram was performed and demonstrated that the filter was in good position although slightly distal with the lower tip projecting into the right iliac.However, the body of the filter is at or above the iliac bifurcation and this position was considered adequate for protection.Post filter implantation, the patient died on an unspecified date and no further details regarding the cause of death are available.Per the patient profile from (ppf), the filter tilted upon deployment.The patient had anxiety, swelling, blood clots, clotting, occlusion of the ivc and the left iliac vein, and that the filter fractured but the location of retained filter strut within the body in unknown.Additionally, the ppf reports the filter was unable to be retrieved; however, no known attempts for removal of the ivc filter have been made.The filter remains implanted; thus, unavailable for analysis.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 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and swelling do not represent a device malfunction and may be related to underlying patient related issues.Death is a known adverse event associated with the use of the ivc filter; however, it does not represent a device malfunction.Further, in this case, the patient had underlying medical issues, specifically the metastatic cancer, that may have contributed to the reported death.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: JUGULAR 55CM KIT
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7349689
• MDR Text Key: 102782396
• Report Number: 9616099-2018-01997
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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 Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 466F230AJ
• Device Lot Number: 17070750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/21/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 04/20/2018; 05/21/2018
• Supplement Dates FDA Received: 05/18/2018; 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR