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U.S. Department of Health and Human Services

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

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Separation (1562)
Patient Problems Embolus (1830); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Common name = unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

A journal article was reviewed, "retrievable inferior vena cava filters can always be removed using 'fall-back' techniques", which detailed a retrospective chart review study conducted of data which was collected of all patients undergoing inferior vena cava filter (ivcf) removal by vascular surgeons at a tertiary academic medical center between 2009 and 2013 including demographics and procedural and filter characteristics. The study objective was to analyze how incorporation of new 'fall back' techniques for filter retrieval which were unsuccessful using standard snaring techniques, affected the outcomes of ivcf retrievals in patients with retrievable ivcf left in place for a prolonged period. The study concluded incorporation of fall back techniques may allow 100% technically successful and safe removal of retrievable ivcfs and is especially useful in removing filters with prolonged dwell time. According to the journal article, during attempted filter retrieval using 'lasso' technique, there were four complications. All occurred with the retrieval of gunther tulip filters by the lasso fallback technique. Three cases involved embolization of fractured bentson wires to the right atrium or pulmonary artery. In one case, a strut of a filter fractured and was left embedded in the caval wall. In all four cases, embolized and retained fragments were successfully snared endovascularly without long-term consequences. Specific procedural, product, and lot number information was not provided. This report is for the fractured filter strut. Please reference medwatches: 1820334-2019-00727; 1820334-2019-00729; and 1820334-2019-00730 for the reports of the fractured wires. Citation: etkin, y. , glaser, j. D. , nation, d. A. , foley, p. J. , wang, g. J. , woo, e. Y. ,. Jackson, b. M. (2015). Retrievable inferior vena cava filters can always be removed using ¿fall-back¿ techniques. Journal of vascular surgery: venous and lymphatic disorders, 3(4), 364-369. Doi:10. 1016/j. Jvsv. 2015. 04. 002.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8467316
MDR Text Key140490438
Report Number1820334-2019-00728
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT 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 Received10/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/29/2019 Patient Sequence Number: 1
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