MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); No Code Available (3191)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter after an automobile accident.The device was positively identified by the patient¿s medical bills as well as the implant pamphlets and card given to the patient at the time.On or about ten years and five months later, the patient complained of pain in the region where her inferior vena cava (ivc) filter was placed.The patient was diagnosed with varicose veins of her lower extremity and hypertension.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care 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 and will have this faulty device permanently implanted along with other injuries.The product was not returned for analysis as it remains implanted.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not be performed.The trapease 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.Abdominal pain, hypertension and varicose veins do not represent a device malfunction.Such events may be related to other comorbidities and not necessarily related to the implantation 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.(b)(4).

Event Description

As reported by the legal brief, the patient on or about (b)(6) 2005 underwent a surgical procedure to implant a trapease permanent vena cava filter after an automobile accident.The device was positively identified by the patient¿s medical bills as well as the implant pamphlets and card given to the patient at the time.On or about (b)(6) 2015, the patient complained of pain in the region where her inferior vena cava (ivc) filter was placed.The patient was diagnosed with varicose veins of her lower extremity and hypertension.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care 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 and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent a procedure to implant a trapease permanent vena cava filter.The patient complained of pain in the region where her inferior vena cava (ivc) filter was placed.The patient was diagnosed with varicose veins of her lower extremity and hypertension.Additional information provided on the patient profile form (ppf) indicated that the patient is experiencing pain and anxiety.The patient¿s medical history is significant for hypertension, low back pain with degenerative joint disease, venous insufficiency with painful bleeding varicose veins, depression, lipoma in the sternum, kidney stone and cholecystectomy.The indication for the filter implant was status post motor vehicle accident injuries of concussion, hemorrhage, broken ribs requiring intensive care treatment and implant of a vena cava filter.The notes also indicate a history of multiple blood clots in the bilateral lower extremities, but the medical documentation regarding deep vein thrombosis (dvt) was not good, per the records.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 trapease 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.A device malfunction has not bee reported at this time.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.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.

Manufacturer Narrative

Additional information was received from the patient profile form that the patient has blood clots, clotting, and/or occlusion of the ivc.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

According to the patient profile form (ppf), the patient¿s medical history, in the attached medical records, is significant for hypertension, low back pain with degenerative joint disease, venous insufficiency with painful bleeding varicose veins, depression, lipoma in the sternum, kidney stone and cholecystectomy.The indication for the filter implant was status post motor vehicle accident injuries of concussion, hemorrhage, broken ribs requiring intensive care treatment and implant of a vena cava filter.The notes also indicate a history of multiple blood clots in the bilateral lower extremities, but the medical documentation regarding deep vein thrombosis (dvt) was not good.There is currently no additional information available.Additional information provided on the patient profile form (ppf) alleges other injuries to be determined by future scans, and that the patient is experiencing pain, suffering, future additional injuries, fear that the implant has moved or will move and cause injury or death.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent a procedure to implant a trapease permanent vena cava filter.The patient complained of pain in the region where her inferior vena cava (ivc) filter was placed.The patient was diagnosed with varicose veins of her lower extremity and hypertension.Additional information provided on the patient profile form (ppf) indicated that the patient is experiencing pain and anxiety and that the patient has blood clots, clotting, and/or occlusion of the ivc.The patient¿s medical history is significant for hypertension, low back pain with degenerative joint disease, venous insufficiency with painful bleeding varicose veins, depression, lipoma in the sternum, kidney stone and cholecystectomy.The indication for the filter implant was status post motor vehicle accident injuries of concussion, hemorrhage, broken ribs requiring intensive care treatment and implant of a vena cava filter.The notes also indicate a history of multiple blood clots in the bilateral lower extremities, but the medical documentation regarding deep vein thrombosis (dvt) was not good, per the records.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 trapease 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, clotting and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and a device malfunction could not be confirmed.A device malfunction has not been reported at this time.Anxiety and pain do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6875497
• MDR Text Key: 86594747
• Report Number: 1016427-2017-00591
• Device Sequence Number: 1
• Product Code: DQO
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 02/06/2018; 02/06/2018; 05/11/2018; 06/10/2018
• Supplement Dates FDA Received: 03/29/2018; 04/03/2018; 06/08/2018; 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 1 NDL FREE UNKNOWN 1 J.V NDL JELCO
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR