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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-CELECT-PT
Device Problems Collapse (1099); Appropriate Term/Code Not Available (3191)
Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Perforation of Vessels (2135); Weakness (2145); Stenosis (2263)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. (b)(4). Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date. Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines. This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters. Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis. Unknown if the reported abscessed filter is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Unknown if the reported retroperitoneal bleed is directly related to the filter and unable to identify a corresponding failure mode at this point in time. Unknown if the reported acute arterial hemorrhage is directly related to the filter and unable to identify a corresponding failure mode at this point in time. No evidence to suggest that this product was not manufactured according to specification. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to categorization form: pt alleges:"ivc is collapsed around filter (chronic ivc stenosis", "ivc is collapsed around the apex of filter (chronic ivc stenosis)", "massive deep venous thromboses", "abscessed ivc filter", "retroperitoneal bleed, acute arterial hemorrhage" additional information received (b)(6) 2019: it is alleged that "pt received a cook celect filter on (b)(6) 2017". Patient outcome: it is alleged that pt was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key8726392
MDR Text Key148973937
Report Number3002808486-2019-00775
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2020
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE3549939
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/31/2019
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2017
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: 06/24/2019 Patient Sequence Number: 1
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