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Catalog Number UNKNOWN
Device Problems Difficult to Remove (1528); Structural Problem (2506)
Patient Problems Chest Pain (1776); Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. This file applies to the patient's caval filter and is being reported in relation to mfr# 3002808486-2021-00138, which regards the patient's iliac filter. Non-healthcare professional. Investigation the reported allegations have been investigated based on the information provided to date. The following allegations have been investigated: vc/aorta/l3 perforation, embedment, unable to remove, dyspnea, physical limitations, chest pain, stomach problems, anxiety, depression. 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 dyspnea, physical limitations, chest pain, stomach problems, anxiety, and depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time. Catalog number and lot number are unknown, however, the alleged tulip is manufactured and inspected according to specifications. 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. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information becomes available.
Event Description
Patient allegedly received a cook celect filter on an unknown date. Patient is alleging vena cava and organ perforation. The patient further alleges "shortness of breath and breathing problems, unable to walk any distances unless short, unable to run at all, chest pains, stomach trouble and problems, movement and activity is severely limited" as well as depression and anxiety. Retrieval report (attempted): "multiple attempts were made to retrieve the inferior vena cava. These were unsuccessful and on oblique imaging it was found that the hook of the caval filter was embedded into the wall of the vena cava. The wire was guided down to the left iliac vein and the sheath advanced over this and the left iliac venogram was obtained. Again, it showed that the hook was embedded into the wall and there was no retrieval attempted. " report from ct: "there is a filter within the left common iliac vein with tines extending extravascularly. There is an infrarenal ivc filter with tines also extending-extravascularly and one of the tines appearing to enter the abdominal aorta and another time penetrating through the cortex of the right anterior inferior corner of the l3 vertebral body. ".
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Manufacturer (Section D)
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
sandet 6
bjaeverskov 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
MDR Report Key11878008
MDR Text Key254553388
Report Number3002808486-2021-01271
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,other
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue 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 Received04/29/2021
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: 05/25/2021 Patient Sequence Number: 1