MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

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

Patient Problems Embolus (1830); Pain (1994); Respiratory Distress (2045); Thrombosis (2100)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of defendants¿ trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, sever pain, respiratory distress, and recurrent deep vein thrombosis (dvt).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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The trapease 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.Clotting, pain, respiratory distress and dvt does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).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 manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Implant date: on or about (b)(6) 2006.

Event Description

As reported by the legal brief, the patient underwent placement of defendants¿ trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, sever pain, respiratory distress, and recurrent deep vein thrombosis (dvt).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.

Manufacturer Narrative

The following additional information received per the medical records indicate that the patient has a history of smoking, chronic obstructive pulmonary disease (copd), hyperlipidemia, respiratory failure, mechanical ventilation, trachea stenosis, sepsis and pneumonia.During the implantation procedure, the filter was implanted for dvt in the infra-renal area.According to the information received in the patient profile form (ppf), the patient became aware of the reported events nine years and four months post implantation.The patient reports that the inferior vena cava (ivc) is occluded and to have had pulmonary embolism (pe) and to be suffering from pain.The device¿s expiration date is april 2009.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, recurrent blood clots, severe pain, respiratory distress, and recurrent deep vein thrombosis (dvt).The patient is also reported to have had a pulmonary embolism (pe) and to have experienced pain.According to the information received the patient became aware of the reported events nine years and four months post implantation.The patient¿s medical history is significant for hypertension, diabetes, splenectomy and a cervical fusion of c4, c5, c6 and c7, smoking, chronic obstructive pulmonary disease (copd), hyperlipidemia, respiratory failure, mechanical ventilation, trachea stenosis, sepsis and pneumonia.Prior to the filter placement the patient presented to the emergency room with progressive shortness of breath, not responsive to nebulizers and steroids and requiring tracheostomy secondary to epiglottitis and was subsequently admitted to the intensive care unit (icu).The patient had a very prolonged hospital course in the icu with several complications such as pe for which he was started on anticoagulation; gastro-intestinal (gi) bleed with an endoscopy that showed esophagitis and duodenitis; ventilatory dependent respiratory failure, pneumonia, enterococcus faecalis bacteremia.The patient developed a sacral decubitus ulcer that required debridement by wound care.The patient was eventually transferred to the floor where he was more stable and started recovering faster.As a result of the poor evolution of the sacral decubitus, it was decided that the patient would have a diverting colostomy, and the patient underwent the colostomy without any complications.Wound care was involved in the case, and the plan was to do a flap two months after the colostomy.The patient was found to have an e.Coli in the urine and in the sacrum and was treated with zosyn.Physical therapy evaluated the patient considering that the patient needed rehabilitation before going home, so the patient was discharged to rehabilitation.The filter was implanted emergently via the right internal jugular vein for the indication of dvt.The procedure noted that the anatomy was suitable for a permanent filter placement in the infrarenal area.There is currently no pertinent additional information available.The product was not returned for analysis.A review of the device history record (dhr) associated with lot r0506242 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.Without films of the index procedure or post implant imaging, the reported device occlusion, clotting and recurrent pe, could not be confirmed and could not be further clarified at this time.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 or a device malfunction could be confirmed.Pain and respiratory distress 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 currently 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• MDR Report Key: 6663428
• MDR Text Key: 78279984
• Report Number: 1016427-2017-00395
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

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: Lay User/Patient
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0506242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 02/28/2018
• Supplement Dates FDA Received: 02/21/2018; 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 57 YR