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

Model Number 466P306AU

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Pain (1994); Depression (2361); Numbness (2415); No Code Available (3191)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

It is noted that the patient also experienced a stroke but no pain is available.Complaint conclusion: it was reported that a patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt).The information provided indicated that the device was opened at the l2-l3 junction.The following additional information received per the medical records indicate that the patient had a history of septic shock, abdominal pain, gastrointestinal (gi) bleed, hypertension and uterine fibroids.The indication for the procedure was a recent gi bleed and extensive left femoral popliteal deep vein thrombosis (dvt).The filter was implanted via the right femoral vein and placed at the right of the l2 and l3 vertebral bodies.Contrast showed the filter was in good position.According to the information received in the patient profile from (ppf), the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient reports the device us unable to be retrieved although there have been no attempts made to remove the filter.The patient also reports to be suffering from depression, loss of feeling in the right foot, pain in the groin area, and to have had two strokes.There is currently no information available on the type of stroke.There is currently no additional information available.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 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, but without procedural or post implant imaging available for review the events could not be confirmed or further clarified.A stroke does not represent a device malfunction and may be related to underlying patient specific issues and or pharmacological factors, the type of stroke, hemorrhagic or thrombotic, was not reported.With the limited information provided and no post implant imaging available for review it is not possible to establish a relationship between the reported events and the device.Anxiety, depression, decreased sensation in the foot and pain in the groin area do not represent a device malfunction, but, rather may be related to underlying patient specific issues.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt).The device was opened at the 12-13 junction.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s installation, the patient has suffered and 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 her body.The following additional information received per the medical records indicate that the patient had a history of septic shock, abdominal pain, gastrointestinal (gi) bleed, hypertension and uterine fibroids.The indication for the procedure was a recent gi bleed and extensive left femoral popliteal deep vein thrombosis (dvt).During the implantation procedure, the filter was placed at the right of the l2 and l3 vertebral bodies.Contrast showed the filter was in good position.According to the information received in the patient profile from (ppf), the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient reports the device us unable to be retrieved although there have been no attempts made to remove the filter.The patient also reports to be suffering from depression, loss of feeling in the right foot, pain in the groin area, and to have had two strokes.There is currently no information available on the type of stroke.

Manufacturer Narrative

Describe event or problem: according to the information received in the amended ppf, the patient no longer reports that the filter was unable to be retrieved and no attempts to remove filter have been noted.Corrected data: initial reporter name and address.(b)(4) is no longer applicable based on the additional information received.It was reported that a patient underwent implant of a trapease permanent vena cava filter.The device in the patient was positively identified by medical records and is still implanted.According to the information received in the patient profile form (ppf), the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).It is also noted that the device is unable to be retrieved although there have been no attempts made to remove the filter.The patient is also reported to be experiencing depression, loss of feeling in the right foot, pain in the groin area, and to have had two strokes.It is unknown if the strokes were embolic or hemorrhagic in nature.According to the information received o- an amended ppf, the patient no longer reports that the filter was unable to be retrieved and no attempts to remove filter have been noted.The indication for the filter implant was a recent gastro-intestinal (gi) bleed and extensive left femoral popliteal deep vein thrombosis (dvt).The records also indicate that the patient had a history of septic shock, abdominal pain, gi bleeding, hypertension and uterine fibroids.The filter was implanted via the right femoral vein and placed at the right of the l2 and l3 vertebral bodies.Contrast showed the filter was in good position.There is currently no additional information available.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 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, but without procedural or post implant imaging available for review the events could not be confirmed or further clarified.A stroke does not represent a device malfunction and may be related to underlying patient specific issues and or pharmacological factors, the type of stroke, hemorrhagic or embolic, was not reported.The timing of the strokes is also unknown.A device malfunction has not been reported at this time.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Anxiety, depression, decreased sensation in the foot and pain in the groin area do not represent a device malfunction, but, rather may be related to underlying patient specific issues.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.Should additional information become available, the file will be updated accordingly.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; cahir road ; EI
• MDR Report Key: 7376908
• MDR Text Key: 103666842
• Report Number: 9616099-2018-02025
• 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
• Report Date: 05/16/2018

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1108156
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/31/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN #11 BLADE; UNKNOWN INTRODUCER; UNKNOWN J WIRE; UNKNOWN MICROPUNCTURE NEEDLEUNKNOWN MICROPUNCTUR; UNKNOWN MICROPUNCTURE SHEATH; UNKNOWN MICROPUNCTURE NEEDLEUNKNOWN MICROPUNCTUR
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR