MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

As reported in the legal file, plaintiff (b)(6) underwent placement of defendants' optease vena cava filter on or about (b)(6) 2009.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, bilateral lower extremity dvt with ivc thrombosis.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. the product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number. the optease 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.Dvt and filter thrombosis do not represent a device malfunction.The reported dvt and filter thrombosis could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As reported in the legal file, plaintiff (b)(6) underwent placement of defendants' optease vena cava filter on or about (b)(6) 2009.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, bilateral lower extremity dvt with ivc thrombosis.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Additional details from medical records were received.At the implant procedure, the venogram with first order selective catheterization of the left common iliac form the right groin puncture and the left renal vein showed patent bilateral common iliac veins, patent inferior vena cava, and a clearly marked left renal vein, the right renal vein is not well visualized.The diameter of the inferior vena cava is less than 30 mm across in the infrarenal segment.The optease ivc filter was successfully deployed with good alignment and well below the renal vein and above the bifurcation of the iliac veins.There was no evidence of thrombosis or thrombus in the ivc or of the filter as shown by the post placement venogram.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported in the legal file, the patient underwent placement of an optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, bilateral lower extremity dvt with ivc thrombosis.Additional information received indicated there were blood blots, clotting, and or occlusion of the ivc.The patient also had pain, leg swelling, extensive bilateral lower extremity dvt, thrombosis below the ivc filter and bilateral external iliac vein thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.Additional details from medical records were received.At the implant procedure, the venogram with first order selective catheterization of the left common iliac form the right groin puncture and the left renal vein showed patent bilateral common iliac veins, patent inferior vena cava, and a clearly marked left renal vein, the right renal vein is not well visualized.The diameter of the inferior vena cava is less than 30 mm across in the infrarenal segment.The optease ivc filter was successfully deployed with good alignment and well below the renal vein and above the bifurcation of the iliac veins.There was no evidence of thrombosis or thrombus in the ivc or of the filter as shown by the post placement venogram.The lot number provided in the medical records is illegible, thus a device history record was unable to be performed.The inferior vena cava (ivc) 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.Thrombosis, clots and treatment for thrombosis does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.(b)(4).

• Brand Name: 466FXXXX
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• Manufacturer Contact: cecil navajas ; po box 025700; miami, FL
• MDR Report Key: 6066893
• MDR Text Key: 58766694
• Report Number: 1016427-2016-00104
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

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 Expiration Date: 04/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: R0508673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/10/2016
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: 10/23/2017; 10/24/2017
• Supplement Dates FDA Received: 11/15/2017; 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention