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

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Hemoptysis (1887); Not Applicable (3189)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

The exact catalog and lot numbers are not known.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: there is specific evidence via a ct scan of the abdomen that the patient¿s filter is tilted against the anterior caval wall.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

Event: the following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due to having a history of pulmonary embolism (pe), deep vein thrombosis (dvt), and an anticoagulation failure.During implantation of the ivc filter via the right common femoral vein, the trapease ivc filter was deployed below the level of the renal veins under direct fluoroscopic guidance.Injection of contrast confirmed filter location and patency of the cava.The patient did well and left the room in stable condition.According to the information received in the patient profile form (ppf), approximately on or about thirteen years and three months post implantation of the ivc filter the patient became aware of the alleged events and reports to have undergone a ct scan for evaluation of their trapease ivc filter.The ct scan report noted that the filter is tilted anteriorly approximately 15 degrees with the superior tip of the filter adjacent to the anterior wall of the ivc.The patient further states to have constant coughing and coughing up blood and to have suffered pain post implant.The patient also states these injuries have cause emotional distress, mental anguish, anxiety, and stress.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: there is specific evidence via a ct scan of the abdomen that the patient¿s filter is tilted against the anterior caval wall.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 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.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.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.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter due to history of pulmonary embolism (pe), deep vein thrombosis (dvt), and an anticoagulation failure.The trapease ivc filter was deployed below the level of the renal veins under direct fluoroscopic guidance.Injection of contrast confirmed filter location and patency of the cava.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to the filter is tilted against the anterior caval wall.Per the patient profile form (ppf), approximately thirteen years and three months post implantation of the ivc filter the patient had a ct scan that noted that the filter is tilted anteriorly approximately 15 degrees with the superior tip of the filter adjacent to the anterior wall of the ivc.The patient further reports anxiety, and constant coughing and coughing up blood and to have suffered pain post implant.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 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.Hemoptysis, coughing blood, is not specifically listed in the ivc filter ifu; however, bleeding issues are a known event following filter implant, and may be related to concomitant anticoagulation therapy.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.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: 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: 8288747
• MDR Text Key: 134466030
• Report Number: 1016427-2019-02460
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0104610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN DELIVERY SHEATH; UNKNOWN WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR