MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306X

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Please note that the event date ((b)(6) 2011) was provided incorrectly in order to meet electronic medwatch acceptance requirements.It is only known that the event began in 2011; the month and day is currently unknown.Please note that the implant date ((b)(6) 2011) was provided incorrectly in order to meet electronic medwatch acceptance requirements.It is only known that the filter was implanted on (b)(6) 2010; the day is currently unknown.The catalog code provided (466p306x), represents an unknown trapease filter.The catalog and lot numbers for the actual product used in the procedure are unknown.This is one of two products involved with the reported adverse events and the associated manufacturer report numbers are 9616099-2015-00675 and 9616099-2015-00676.Complaint conclusion: as reported by the patient, he had "two trapease vena cava filter placed in both the right and left leg." the patient stated he had the surgery back in (b)(6) 2010 to prevent blood clots.He stared to get clots in 2011, further clarified as pulmonary embolisms and full filters.The patient was in the hospital, and has been hospitalized for the past two weeks due to clots in his filters and pain in his hips from the implanted filters.Lot number is unknown.The devices remain implanted in the patient.A device history record (dhr) review could not be conducted for the products as a lot number was not provided.A pulmonary embolism (pe) is the sudden blockage of a major blood vessel (artery) in the lung, usually by a blood clot.In most cases, the clots are small and are not fatal; however, they can damage the lungs.If a clot is large enough, it can stop blood flow to the lungs and lead to death.As provided in the ifu, ¿trapease filter is designed to prevent pulmonary embolism while maintaining caval patency.¿ inferior vena cava filters are used to prevent pe in patients with contraindications to, complications of, or failure of anticoagulation therapy and patients with extensive free-floating thrombi or residual thrombi following massive pe.Pes occurring after a trapease filter has been implanted is a known potential adverse event and is listed in the ifu as such.Current evidence indicates that ivc filters are largely effective with breakthrough pe occurring in only 0% to 6.2% of cases.As reported by the patient, the filters implanted were filled with thrombosis about a year after implantation due to pre-existing deep vein thrombosis (dvt) located in both legs.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.Thrombus in the filter does not represent a device malfunction, is a well-known potential complication, and occurs in approximately 3.6 to 11.2 % of all patients¿.Factors that may have influenced the events include patient, pharmacological and operational.In this case, the patient mentioned that two trapease ivc filters were implanted in both legs, which is an unintended use and is against the ifu.According to the ifu, the trapease filter is to be implanted in the inferior vena cava and only one filter should be implanted.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.However, based on the information reported, there is no indication that the event was related to a design or manufacturing issue.Therefore, no corrective and preventive actions will be taken at this time.

Event Description

As reported by the patient, he had "two trapease vena cava filter placed in both the right and left leg." the patient stated he had the surgery back in (b)(6) 2010 to prevent blood clots.He stared to get clots in 2011, further clarified as pulmonary embolisms and full filters.The patient was in the hospital, and has been hospitalized for the past two weeks due to clots in his filters and pain in his hips from the implanted filters.Lot number is unknown.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5330579
• MDR Text Key: 34502378
• Report Number: 9616099-2015-00675
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANOTHER UNKNOWN TRAPEASE FILTER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention