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Catalog Number UNKNOWN
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Great Vessel Perforation (2152); Cramp(s) (2193)
Event Type  Injury  
Manufacturer Narrative
Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook gunther tulip filter. Occupation: non-healthcare professional. Pma/510(k) k172557. Summary of investigational findings: the reported allegations have been 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. 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. Unknown if the reported pain, emotional changes are directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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 of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on or about (b)(6) 2013. " alleged "in (b)(6) of 2018, [pt] was suffering from chest and abdominal pain, so her doctor ordered a computed tomography (ct) scan of her abdomen and pelvis. It was discovered that the cook filter struts had moved since the filter was placed, with all of the struts perforating the inferior vena cava and at least one of the struts extending to [pt] abdominal aorta. That same year, doctors attempted to remove the cook filter; however, the cook filter would not yield due to the filter's embedment in the ivc and doctors abandoned the procedure. In (b)(6) of 2018, [pt] underwent a second attempt to remove the cook filter. Her doctors were ultimately able to remove the filter its in entirety. Patient outcome: alleged " [pt] has suffered and will continue to suffer serious physical injuries, pain and suffering, mental anguish, loss of enjoyment of life, disability, and other losses".
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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 Key9919470
MDR Text Key186552428
Report Number3002808486-2020-00393
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 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received08/04/2020
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

Patient Treatment Data
Date Received: 04/03/2020 Patient Sequence Number: 1