MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE® VENA CAVA FILTER; VENA CAVA FILTER, PERMANENT

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

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 12/19/2018

Event Type  Injury  

Event Description

The problem was that the patient had a clot formation during elective removal of an ivc filter (had been in place for ~13 years).The clot was retrieved during the interventional radiology procedure and heparin was administered.The patient was managed on an inpatient floor after the procedure with low systolic blood pressure (~100 mmhg).Requiring blood products; she sustained a cardiac arrest and subsequently died.The death is not directly related to a defect in the equipment used during the interventional radiology case or with the ivc filter itself.Procedure: inferior vena cavogram.Removal of cordis trapease ivc filter.Mechanical thrombectomy of ivc with penumbra device.Thrombolysis and mechanical thrombectomy of ivc with angiojet device.Tunneled small bore catheter removal.The patient went for ivc filter removal, afterwards was hypotensive and bleeding requiring transfusion.During the procedure, after the ivc filter was removed, the endothelium was reported to have been damaged and a clot formed.The interventional radiologist/proceduralist was able to aspirate the clot, but the ir team was worried that the clot would reform quickly.Given bleeding and risk for continued bleeding, the inpatient medicine team struggled to make the determination if it was safe to initiate anticoagulation therapy immediately via a continual infusion or was it prudent to wait to allow the bleeding to be under better control.The patient was eventually started on anticoagulation (heparin) and within a couple of hours after starting the anticoagulation, the patient sustained a pea arrest and died.The medicine team reported that they believed that the patient ultimately died from a pulmonary embolism related to being post-ivc filter.Removal: the medicine team outlined that the removal of the ivc led her to have a clot in her inferior vena cava that broke free and traveled to lungs.The medicine team did not initiate anticoagulation infusion immediately post-op when the patient arrived to the inpatient area because she was bleeding and hypotensive.In further discussion with the ir team, the ir/radiology team suggested that the anticoagulation be initiated despite the bleeding.There was ongoing communication between the medicine team and the ir/radiology team overnight (post-procedure), but it was not specifically clear which option regarding when to start the anticoagulation would be the best.It can not be determined if this event ultimate event could have prevented by starting the anticoagulation infusion earlier, but this will be reviewed and discussed.

• Brand Name: TRAPEASE® VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER, PERMANENT
• Manufacturer (Section D): CORDIS CORPORATION; 1820 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 8225817
• MDR Text Key: 132356960
• Report Number: 8225817
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2019
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23725 DA
• Patient Weight: 57