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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 12/08/2016
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a gunther tulip filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Corrected data compared to sus voluntary event report mw5066691. Device available for evaluation: y. Investigation is still in progress.

 
Event Description

Description og event according to initial reporter: attempted removal (b)(6) 2015 apparently left intact at that time. Found to be fractured on ct (b)(6) 2016 with leg in right renal parenchyma, this piece was not removed. 3/4 thin wires were broken, one free/stuck in filter, other two still attached, all removed. Also tip embedded. Forceps retrieval (b)(6) 2016. Description og event according to sus voluntary event report mw5066691: gunther ivc filter found to be fractured with one leg in the right renal parenchyma (extravascular) and one of the thin wires fractured and captured in the filter. Two other thin wires also fractured. Pt had a prior removal attempt in 2015, but fracture appears to have occurred after that. Removed with forceps today renal fragment in pt. Patient outcome requested but not provided.

 
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a gunther tulip filter. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Corrected data compared to sus voluntary event report mw5066691. Device available for evaluation: y. Summary of investigational findings: investigation is solely based on description of event. No product is returned and no image is provided. According to the complaint report, three filter was fractured; one (primary, assumed) leg in the right renal parenchyma (extravascular) and three secondary legs (one located in the filter). Patient had a prior removal attempt in 2015, "but fracture appears to have occurred after that. " it is noted, that the filter was removed - but the renal fragment remains in the patient. No conclusion can be drawn based on the incomplete information provided, but it is assumed filter fractured during reported retrieval attempt. Filter fracture is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e. G. Renal vein), excessive force or manipulations near an implanted filter (e. G. A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter. It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible. No evidence to suggest that this device was not manufactured according to specifications and 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 medical will continue to monitor for similar events.

 
Event Description

Description og event according to initial reporter: attempted removal (b)(6) 2015 apparently left intact at that time. Found to be fractured on ct (b)(6) 2016 with leg in right renal parenchyma, this piece was not removed. The 3/4 thin wires were broken, one free/stuck in filter, other two still attached, all removed. Also tip embedded. Forceps retrieval (b)(6) 2016. Description og event according to sus voluntary event report mw5066691: gunther ivc filter found to be fractured with one leg in the right renal parenchyma (extravascular) and one of the thin wires fractured and captured in the filter. Two other thin wires also fractured. Pt had a prior removal attempt in 2015, but fracture appears to have occurred after that. Removed with forceps today renal fragment in pt. Patient outcome: requested but not provided.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key6212128
MDR Text Key63474810
Report Number3002808486-2016-01554
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
Report Date 12/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
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 Received12/13/2016
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

Patient TREATMENT DATA
Date Received: 12/29/2016 Patient Sequence Number: 1
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