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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
As reported in the literature article by buso, g. , alatri, a. , calanca, l. , fresa, m. , qanadli, s. D. , pesavento, r. , & mazzolai, l. (2020). Why optional inferior vena cava filters are not always retrieved? a real world 19 years experience in a swiss tertiary care university hospital. European journal of internal medicine, 76, 64¿70. Https://doi. Org/10. 1016/j. Ejim. 2020. 01. 025, one patient with an optease filter had an ivc perforation without serious complications. The device was not returned for analysis. A product history record (phr) review could not be conducted as a lot number was not provided. The reported ¿inferior vena cava perforation¿ could not be confirmed as the device was not returned for analysis. The exact cause of the reported event could not be conclusively determined. Procedural factors, such as operator technique, or vessel characteristics, although unknown, may have contributed to the reported event. According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿the optease® retrievable filter can be retrieved up to and including 12 days after placement. The optease® retrievable filter is considered a permanent implant if it is not retrieved within the specified time period. Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during the procedure. Possible retrieval procedure complications include, but are not limited to, the following: air embolism, hematoma at the puncture site, rupture of the vessel wall, perforation of the vessel wall, intimal tear, inability to retrieve the filter, inability to push the retrieval catheter over the filter, restriction of blood flow, distal embolization, infection and/or filter fracture. ¿ without a lot number to conduct a phr review, or any other product information, it is not possible to make a clinical decision whether the reported event could be related to the manufacturing process; therefore, no corrective and preventive actions will be taken at this time.
 
Event Description
As reported in the literature article by buso, g. , alatri, a. , calanca, l. , fresa, m. , qanadli, s. D. , pesavento, r. , & mazzolai, l. (2020). Why optional inferior vena cava filters are not always retrieved? a real world 19 years experience in a swiss tertiary care university hospital. European journal of internal medicine, 76, 64¿70. Https://doi. Org/10. 1016/j. Ejim. 2020. 01. 025, one patient with an optease filter had an ivc perforation without serious complication. The device will not be returned for evaluation.
 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12202236
MDR Text Key262633190
Report Number9616099-2021-04717
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Event Location No Information
Date Manufacturer Received06/22/2021
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

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