• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Failure to Capture (1081); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); No Code Available (3191)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Two unsuccessful retrieval attempt on (b)(6) 2014. Catalog #: unknown cook celect filter. Expiration date: unknown as lot # is unknown. Since catalog # is unknown the 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629. Mfr date unknown as lot # is unknown. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: the patient had a cook celect ivc filter implanted on (b)(6) 2014 for a laminectomy procedure to treat his sciatica. His physician had initially intended to remove the filter within 10 days after the laminectomy procedure. His first unsuccessful retrieval attempt occurred in (b)(6) 2014. His second unsuccessful retrieval attempt occurred in (b)(6) 2014. The patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems. His legs are swollen, tight and full of pressure. He has had to use a walker since his filter placement procedure. He believes that the cook celect ivc filter may be the cause of his problems. He is having another laminectomy procedure soon that could improve some of his symptoms but he has been told by his surgeon that the laminectomy will not help his leg problems. The patient has recently had an ultrasound that showed that the filter is in his abdomen. A different physician will soon be attempting to confirm this with x-ray. The patient is very worried that his filter has moved or could move in a dangerous way. Patient outcome: the patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems. His legs are swollen, tight and full of pressure. He has had to use a walker since his filter placement procedure.

 
Manufacturer Narrative

(b)(4). Date of event: two unsuccessful retrieval attempt on (b)(6) 2014. Catalog#: unknown cook celect filter. Since catalog# is unknown the 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629. (b)(4). Summary of investigational findings: investigation is solely based on event description since no imaging is provided and no product is returned. Additional information states, that the filter has not migrated to pt's abdomen, but it is tilted and has not been retrievable in two attempts. However, without a medical report/imaging it would be inappropriate to speculate on what may have led to the failure mode. Nor would it be appropriate to comment on the patient's medical condition following operation and filter placement. The complaint will be reopened, if imaging or additional information is provided. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk. Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques. 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 initial reporter: the patient had a cook celect ivc filter implanted on (b)(6) 2014 for a laminectomy procedure to treat his sciatica. His physician had initially intended to remove the filter within 10 days after the laminectomy procedure. His first unsuccessful retrieval attempt occurred in (b)(6) of 2014. His second unsuccessful retrieval attempt occurred in (b)(6) of 2014. The patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems. His legs are swollen, tight and full of pressure. He has had to use a walker since his filter placement procedure. He believes that the cook celect ivc filter may be the cause of his problems. He is having another laminectomy procedure soon that could improve some of his symptoms but he has been told by his surgeon that the laminectomy will not help his leg problems. The patient has recently had an ultrasound that showed that the filter is in his abdomen. A different physician will soon be attempting to confirm this with x-ray. The patient is very worried that his filter has moved or could move in a dangerous way. According to the physician "the filter has not migrated to the patient's abdomen. It is tilted and has not be retrievable in two attempts" patient outcome: the patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems. His legs are swollen, tight and full of pressure. He has had to use a walker since his filter placement procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5982373
MDR Text Key55790097
Report Number3002808486-2016-01167
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2016
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

-
-