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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Fracture (1260); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2019
Event Type  Injury  
Manufacturer Narrative
The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and fractured.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt and fracture events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: fracture and tilt.
 
Manufacturer Narrative
Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of menorrhagia and recurrent deep vein thrombosis and had been admitted for a laparoscopic hysterectomy.Prior to this surgery, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have tolerated the procedure well.Approximately six years and ten months after the filter implantation, the patient became aware that the filter had tilted and fractured with filter strut(s) retained within the inferior vena cava (ivc).The patient further reported having experienced mental anguish, worry and anxiety associated with the filter.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt and fracture events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: fracture and tilt.The following additional information was received per medical records: the patient was admitted for a robotic-assisted laparoscopic hysterectomy with indication of menorrhagia and recurrent dvt.Following the successful close of this procedure, an optease ivc filter was implanted.The patient tolerated the procedure well.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 6 years and 10 months post implantation.The patient reports filter fracture and filter tilt.The ivc filter fractured strut(s) remain within the ivc.The patient also reports suffering from anxiety.
 
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Brand Name
466FXXXX
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 ave
miami lakes FL 33014
MDR Report Key9887822
MDR Text Key188516079
Report Number1016427-2020-03967
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Date Manufacturer Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age46 YR
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