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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Fracture (1260); Occlusion Within Device (1423); Failure to Align (2522)
Patient Problems Death (1802); Hematoma (1884); Perforation (2001); Thrombosis (2100)
Event Date 05/24/2016
Event Type  Death  
Manufacturer Narrative
As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. The device subsequently malfunctioned, fractured, and perforated his vena cava, causing among other things, the loss of blood and the formation of a retroperitoneal hematoma, and death approximately eight years/eight months and eighteen days after filter placement. At the time of death, the patient was a regular, full-time employee of a bakery. As per the patient¿s death certificate: ¿the immediate cause of death as per the death certificate was a large retroperitoneal hematoma and underlying causes: perforation of the ivc and broken ivc filter. Other contributing factors as per the death certificate were atherosclerotic cardiovascular disease. The manner of death as per the death certificate was accident. The final anatomical diagnosis as per the plaintiff¿s death certificate: large retroperitoneal hematoma due to perforation of the inferior vena cava by broken ivc filter. Large retroperitoneal hematoma measuring 30 cm in greatest dimension. Defect of the inferior vena cava. Broken ¿leg¿ of the ivc filter. Ivc filter occluded by embolus. Bilateral pulmonary edema. Ill. Atherosclerotic cardiovascular disease with 90% of focal calcified narrowing of the left anterior descending coronary artery. Right pleural adhesions. Anthracotic pigmentation of both lungs'. Status post right thoracotomy and craniotomy, remote. Cpr related injuries. Numerous rib fractures. Fracture of the sternum. There is an ivc filter in the inferior vena cava identified. The filter is deviated approximately 15 degrees from the central axis with tip of the filter fused to the sidewall of the vena cava. The filter is completely occluded by embolus with a blood clot present over the superior aspect of the filter. The left side of the inferior vena cava displays an almost round defect measuring 0. 3 cm in diameter. Examination of the filter revealed one broken "leg" of the filter with sharp edge located approximately 0. 5 cm from the inferior vena cava defect. ¿ no additional information is available. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. 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. Thrombus within the device does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films for review, the filter tilt reported could not be confirmed. The timing and mechanism of the reported tilt is unknown at this time. Without procedural films for review, the reported filter fracture/separated could not be confirmed and the exact cause could not be determined. It could not be conclusively determined to be a contributing factor to the retroperitoneal hemorrhage. The instructions for use (ifu) states filter fracture is a potential complication 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. Additionally, it is unknown if the filter tilt/fracture contributed to the reported ivc perforation and hemorrhage as procedural films are not available for review. The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. 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. Please note that this is the initial/final report for this product.
 
Event Description
As reported through the legal department, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter. The device subsequently malfunctioned, fractured, and perforated his vena cava, causing among other things, the loss of blood and the formation of a retroperitoneal hematoma, and death approximately eight years/eight months and eighteen days after filter placement. That at the time of his death, the plaintiff was a regular, full-time employee of a bakery.   as per the plaintiff's death certificate: the immediate cause of death as per the plaintiff¿s death certificate was a large retroperitoneal hematoma and underlying causes: perforation of the ivc and broken ivc filter. Other contributing factors as per the death certificate were atherosclerotic cardiovascular disease. The manner of death as per the death certificate was accident. The final anatomical diagnosis as per the plaintiff¿s death certificate: large retroperitoneal hematoma due to perforation of the inferior vena cava by broken ivc filter. Large retroperitoneal hematoma measuring 30 cm in greatest dimension. Defect of the inferior vena cava. Broken ¿leg¿ of the ivc filter. Ivc filter occluded by embolus. Bilateral pulmonary edema. Ill. Atherosclerotic cardiovascular disease with 90% of focal calcified narrowing of the left anterior descending coronary artery. Right pleural adhesions. Anthracotic pigmentation of both lungs'. Status post right thoracotomy and craniotomy, remote. Cpr related injuries. A. Numerous rib fractures. Fracture of the sternum. There is an ivc filter in the inferior vena cava identified. The filter is deviated approximately 15 degrees from the central axis with tip of the filter fused to the sidewall of the vena cava. The filter is completely occluded by embolus with a blood clot present over the superior aspect of the filter. The left side of the inferior vena cava displays an almost round defect measuring 0. 3 cm in diameter. Examination of the filter revealed one broken "leg" of the filter with sharp edge located approximately 0. 5 cm from the inferior vena cava defect. No additional information is available.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
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
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6615029
MDR Text Key76770718
Report Number1016427-2017-00347
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/22/2017
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2017 Patient Sequence Number: 1
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