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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 05/07/2021
Event Type  Injury  
Manufacturer Narrative
As reported in the literature article by elboraey, m. , toskich, b. B. , lewis, a. R. , ritchie, c. A. , frey, g. T. , & devcic, z. (2021). Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts. Journal of vascular surgery cases and innovative techniques, 7(3), 454¿457. Https://doi. Org/10. 1016/j. Jvscit. 2021. 05. 006, eleven years after implantation, computed tomography (ct) and venography demonstrated a trapease ivc filter was thrombosed and calcified with complete occlusion to the bilateral common femoral veins (cfv). The patient required recanalization for iliocaval occlusion. Pharmacomechanical thrombectomy was followed by filter exclusion and iliocaval reconstruction with parallel, bilateral, overlapping 12mmx80mm and 14mmx80mm smart ses stents dilated using venoplasty. An acute thrombus had formed within the smart ses stents secondary to severe narrowing by the filter. The smart ses stents were then reinforced with a non cordis balloon expandable stent-graft. The patient was hospitalized for 1 day. Six month follow up demonstrated patent bilateral cfvs, femoral veins (fvs),and popliteal veins (pvs). 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 ¿thrombosis vena cava inferior and occlusion¿ could not be confirmed as the device was not returned. The exact cause of the reported events 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 trapease vena cava filter is designed for percutaneous delivery of a permanent vena cava filter to the ivc. Possible procedure complications include, but are not limited to, occlusion of small vessel and thrombus formation. ¿ thrombosis and/or occlusion within the device or within the ivc does not represent a device malfunction. Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics. 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 design or manufacturing process; therefore, no corrective and preventive actions will be taken at this time.
 
Event Description
As reported in the literature article by elboraey, m. , toskich, b. B. , lewis, a. R. , ritchie, c. A. , frey, g. T. , & devcic, z. (2021). Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts. Journal of vascular surgery cases and innovative techniques, 7(3), 454¿457. Https://doi. Org/10. 1016/j. Jvscit. 2021. 05. 006, eleven years after implantation, computed tomography (ct) and venography demonstrated a trapease ivc filter was thrombosed and calcified with complete occlusion to the bilateral common femoral veins (cfv). The patient required recanalization for iliocaval occlusion. Pharmacomechanical thrombectomy was followed by filter exclusion and iliocaval reconstruction with parallel, bilateral, overlapping 12mmx80mm and 14mmx80mm smart ses stents dilated using venoplasty. An acute thrombus had formed within the smart ses stents secondary to severe narrowing by the filter. The smart ses stents were then reinforced with a non cordis balloon expandable stent-graft. The patient was hospitalized for 1 day. Six month follow up demonstrated patent bilateral cfvs, femoral veins (fvs),and popliteal veins (pvs). The devices will not be returned for analysis.
 
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Brand NameUNKNOWN TRAPEASE
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
MDR Report Key12710471
MDR Text Key284290854
Report Number9616099-2021-05021
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466P306X
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
Treatment
VIABAHN 11MMX79MM STENT X2
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