MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE W/CSI INTRO KIT 55CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: triple lumen catheter.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 the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from thrombotic event post implant.The following additional information was received per the patient¿s implant records: the filter was implanted due to abscess drainage.The trapeze filter was deployed in the infrarenal ivc.Post filter placement, the filter was seen in good position.Patient had a history of deep venous thrombosis (dvt).According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately fifteen years post implantation.The patient reports blood clots, clotting at and below the filter, growth of collateral veins and/or occlusion of the ivc.The patient also reports suffering from anxiety.Concomitant medical products: triple lumen catheter.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the filter was implanted due to a history of deep vein thrombosis (dvy) and the need for abscess drainage.The trapeze filter was deployed in the infrarenal ivc.Post filter placement, the filter was seen in good position.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from thrombotic event post implant.Per the patient profile form (ppf), the patient reports blood clots, clotting at and below the filter, growth of collateral veins and/or occlusion of the ivc.The patient also reports suffering from anxiety.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.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation is a known potential event associated with the filter device, patent specific issues, thrombus formation, may contribute to this event.Anxiety does 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 W/CSI INTRO KIT 55CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8436109
• MDR Text Key: 139317955
• Report Number: 1016427-2019-02631
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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: 04/05/2019
• 2 Devices were Involved in the Event: 1 2

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: 466P306X
• Device Catalogue Number: 466P306X
• Device Lot Number: R0901608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR