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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
Model Number G34502
Device Problems Structural Problem (2506); Device Tipped Over (2589)
Patient Problems Edema (1820); Internal Organ Perforation (1987); Perforation of Vessels (2135); Great Vessel Perforation (2152)
Event Type  Injury  
Manufacturer Narrative

Manufacturers ref# (b)(4). Catalog# is unknown but referred to as cook celect filter. Occupation: non-healthcare professional. Summary of investigational findings. The reported allegations have been further investigated based on the information provided to date. Filter interacts with ivc wall, e. G. Penetration/perforation/embedment. This may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration. Filter tilt has been reported. Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt. Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency. Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt. The following allegations have been investigated: inferior vena cava (ivc) perforation and tilt. The device history record was reviewed with no evidence to suggest that this device was not manufactured according to specifications. Nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2016, [pt] was implanted with a cook celect vena cava filter. On or about (b)(6) 2017, [pt] underwent a computed tomography (¿ct¿) scan of his abdomen and pelvis. The ct scan revealed that the cook ivc filter struts had moved since the filter was placed, with several of the struts extending outside [pt's] inferior vena cava. The (b)(6) 2017 ct also revealed that [pt's] cook ivc filter had subsequently tilted since the filter was placed". Patient outcome: it is alleged that "[pt] is at risk for future cook ivc filter fractures, migrations, perforations, and tilting. [pt] faces numerous health risks, including the risk of death. For the rest of his life, [pt] will require ongoing medical care and monitoring".

 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key10084938
MDR Text Key191966830
Report Number3002808486-2020-00557
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 06/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/24/2017
Device MODEL NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device LOT NumberE3197015
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2014
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: 05/25/2020 Patient Sequence Number: 1
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