MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 09/01/2009

Event Type  Injury  

Manufacturer Narrative

As reported by the legal team, plaintiff underwent placement of defendants' optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).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 device was not returned for analysis.   a device history record (dhr) review could not be conducted as the sterile lot number was not provided.  without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.Neither blood clots, clotting nor thrombus within the vessel (or in the filter) represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The product¿s instructions for use (ifu) indicate that filter obstruction and thrombus formation are potential complications of filter implantation.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 by the legal team, plaintiff underwent placement of defendants' optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc filter, and recurrent deep vein thrombosis (dvt).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

After further review of additional information received the following sections have been updated accordingly.As reported by the legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient had a history of deep vein thrombosis (dvt), lower extremity swelling and was morbidly obese.The filter was successfully deployed at the level of the l3 vertebrae between the renal veins and the bifurcation of the ivc although the vessel was somewhat tortuous which made the filter appear tilted.However, the final venogram showed that the filter was indeed centered.The patient tolerated the index procedure well and was taken to recovery in stable condition.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent dvt.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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.Per the patient profile from (ppf), two years and five months post implantation the patient had a stroke, has pain in the groin area and is anxious.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot rg17853388 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The optease 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.A tia is a temporary blockage of blood flow to the brain and does not represent a device malfunction.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Clinical factors that may have influenced the event include patient comorbidities, specifically coagulopathy, 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.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that two years and five months post implantation the patient had a stroke, has pain in the groin area and is anxious.According to the medical records, the patient had a history of dvt, lower extremity swelling and was morbidly obese.The filter was successfully deployed at the level of the l3 vertebrae between the renal veins and the bifurcation of the ivc although the vessel was somewhat tortuous which made the filter appear tilted.However, the final venogram showed that the filter was indeed centered.The patient tolerated the index procedure well and was taken to recovery in stable condition.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6518283
• MDR Text Key: 73604735
• Report Number: 1016427-2017-00292
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

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 Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R1106416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2017
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 01/11/2018
• Supplement Dates FDA Received: 01/03/2018; 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 53 YR