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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 Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
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, two years after implantation, computed tomography (ct) demonstrated a thrombosed trapease ivc filter with completely thrombosed, expanded, and edematous bilateral iliofemoral and popliteal veins (pvs). The patient required recanalization for symptomatic iliocaval occlusion. Pharmacomechanical thrombectomy was followed by ivc filter exclusion and iliocaval reconstruction with parallel bilateral overlapping non-cordis ses dilated using venoplasty. Because of the recurrent thrombus formation within the non-cordis stents that developed overnight, thrombolysis was initiated. Subsequently, the non-cordis ses were severely narrowed by the ivc filter. Thus, they were reinforced with parallel non cordis balloon expandable stent-graft. This patient developed transient acute kidney injury from contrast administration. He was hospitalized for 7 days. Eleven 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 in device and edema vascular¿ could not be confirmed as the device was not returned. 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. The trapease 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 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. Thrombosis in device or vascular edema do 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 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, two years after implantation, computed tomography (ct) demonstrated a thrombosed trapease ivc filter with completely thrombosed, expanded, and edematous bilateral iliofemoral and popliteal veins (pvs). The patient required recanalization for symptomatic iliocaval occlusion. Pharmacomechanical thrombectomy was followed by ivc filter exclusion and iliocaval reconstruction with parallel bilateral overlapping non-cordis ses dilated using venoplasty. Because of the recurrent thrombus formation within the non-cordis stents that developed overnight, thrombolysis was initiated. Subsequently, the non-cordis ses were severely narrowed by the ivc filter. Thus, they were reinforced with parallel non cordis balloon expandable stent-graft. This patient developed transient acute kidney injury from contrast administration. He was hospitalized for 7 days. Eleven month follow up demonstrated patent bilateral cfvs, femoral veins (fvs),and popliteal veins (pvs). The device will not be returned for evaluation.
 
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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
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 Key12703795
MDR Text Key278542760
Report Number9616099-2021-05011
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? No
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: 10/27/2021 Patient Sequence Number: 1
Treatment
ENOXAPARIN; IOHEXOL CONTRAST; PROTÉGÉ 10MMX80MM STENT (MEDTRONIC) X2; VIABAHN VBX STENT (GORE) (11MMX79MM) X2; VICI VENOUS 14MMX120MM STENT (BOSTON SCIENTIFIC) X; VICI VENOUS 16MMX90M STENT (BOSTON SCIENTIFIC) X2
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