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

Catalog Number 466P306X

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Perforation (2001); Thrombosis (2100)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported via the legal department, notification of legal action was received involving four plaintiffs.Plaintiff number two (#2), underwent placement of a trap ease filter which subsequently malfunctioned.The device, inter alia, fractured, perforated his vena cava, and caused thrombosis of the vena cava and filter.As a result of these malfunctions, he suffered life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.

Manufacturer Narrative

As reported via the legal department, notification of legal action was received.One plaintiff underwent placement of a trapease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, fractured, perforated his vena cava, and caused thrombosis of the vena cava and filter.As a result of these malfunctions, he suffered life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.The device remains implanted in the patient and is not available for inspection.Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available.The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter or within the vessel does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately 3.6 to 11.2% of all patients.As such, it is addressed in the product¿s instructions for use (ifu).Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics.The reported ¿filter fracture¿ could not be confirmed as the filter was not available for analysis nor were procedural films were not provided for review.As such, the root cause of the fracture could not be determined.Based on the limited information for review, factors contributing to the fracture could not be conclusively determined.The ifu states filter fracture and perforation of the vena cava wall are potential complications of implantation of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Based on the limited information available for review, there is no indication of a design or manufacturing related cause for this event.Therefore, no corrective action will be taken at this time.Should additional information become available, the file will be updated accordingly.

• 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: 5650982
• MDR Text Key: 45052323
• Report Number: 9616099-2016-00232
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening