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Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Occupation: non health care professional. Pma/510(k) k172557. Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date. Filter fracture has been reported and may be either symptomatic or asymptomatic. Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e. G. , a renal vein). Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported. Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures. Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up. The risks/benefits of filter retrieval should be considered for each patient during follow-up. Once protection from pe is no longer necessary, filter retrieval should be considered. Filter retrieval should be attempted when feasible and clinically indicated. Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e. G. , a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications). For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set. It may also be retrieved with the cloversnare® vascular retriever. Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques. The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position. The safety or effectiveness of these alternative retrieval techniques has not been established. Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve. For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth. 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 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 "[pt] received a gunther tulip filter on (b)(6) 2014. On (b)(6) 2016, after 2 hours of attempted filter removal the procedure was aborted as the hook broke the hook off the filter, and doctors were unable to the entire filter removed from [pt]'s ivc. Doctors took further precautions by implanting a second suprarenal filter to catch clot, as the broken gunther tulip filter was no longer expanded and/or useful to catch thrombus as it was designed. " patient outcome: it is alleged that "[pt] is at risk for future progressive perforations by the remaining portion of the gunther tulip filter which could further injure adjacent organs, blood vessels, and structures, as well as increased risk of migration of the gunther tulip ivc filter pieces. [pt] faces numerous health risks, including the risk of death. [pt] will require ongoing medical care and monitoring for the rest of her life. It is unknown if the remaining filter pieces can be retrieved by any means other than an open surgical procedure. ".

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Manufacturer (Section D)
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
MDR Report Key10383538
MDR Text Key202189863
Report Number3002808486-2020-00757
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
Report Date 08/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
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

Date Received: 08/10/2020 Patient Sequence Number: 1