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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4) catalog # unknown as information was not provided but referred to as a cook celect filter. As catalog # is unknown it could be either k061815, k073374 or k090140. Investigation is still in progress.

 
Event Description

Description of event according to the published article (mintz jd et al. , 2015): "a retrieval attempt of a celect ivc filter placed at an outside hospital failed, and the patient was referred for complex filter retrieval with forceps. Subtracted image from rotational venacavogram shows tip embedding (black arrow) and deep penetration and distortion of one of the filter legs (white arrow). Subtracted image after forceps retrieval shows caval pseudoaneurysm (arrow) at the site of the penetrated leg. Treatment comprised three cycles of balloon tamponade (with balloon size approximating caval diameter and sequential 5-min inflations until resolution). The patient was asymptomatic, and vital signs remained stable. Subtracted image after balloon tamponade shows persistent pseudoaneurysm (arrow), which was stable. The patient was admitted for observation and remained hemodynamically stable and asymptomatic. A computed tomography scan (not shown) performed the next day showed near-complete resolution and no significant hematoma. Image from magnetic resonance venography performed at 1-month follow-up evaluation shows normal ivc. The patient returned for a second temporary ivc filter placement 4 years later. Subtracted image from venacavography performed before placement shows normal ivc. " patient outcome: patient required complex filter retrieval and three cycles of balloon tamponade. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Catalog number unknown as information was not provided but referred to as a cook celect filter. As catalog number is unknown it could be either k061815, k073374 or k090140. Summary of investigational findings: according to the description of the event a retrieval attempt of a filter failed, and the patient was referred for complex filter retrieval with forceps. Investigation of the imaging showed filter perforation by a primary filter leg prior to retrieval. Patient medical history is unknown at this time. The root cause for the event is not possible to determine. Filter perforation of the vena cava wall is a known risk reported in the published scientific literature. Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall. Filter retrieval is occasionally difficult. Difficult filter retrieval due to embedment of filter legs in the ivc wall is a well-known risk in the literature. Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques. This is well-known from published scientific literature where filter retrievals are referred to as simple vs complex. 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 the published article (mintz jd et al. , 2015): "a retrieval attempt of a celect ivc filter placed at an outside hospital failed, and the patient was referred for complex filter retrieval with forceps. (a) subtracted image from rotational venacavogram shows tip embedding (blackarrow) and deep penetration and distortion of one of the filter legs (whitearrow). (b) subtracted image after forceps retrieval shows caval pseudoaneurysm (arrow) at the site of the penetrated leg. Treatment comprised three cycles of balloon tamponade (with balloon size approximating caval diameter and sequential 5-min inflations until resolution). The patient was asymptomatic, and vital signs remained stable. (c) subtracted image after balloon tamponade shows persistent pseudoaneurysm (arrow), which was stable. The patient was admitted for observation and remained hemodynamically stable and asymptomatic. A computed tomography scan (not shown) performed the next day showed near-complete resolution and no significant hematoma. (d) image from magnetic resonance venography performed at 1-month follow-up evaluation shows normal ivc. (e) the patient returned for a second temporary ivc filter placement 4 years later. Subtracted image from venacavography performed before placement shows normal ivc. " patient outcome: patient required complex filter retrieval and three cycles of balloon tamponade. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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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 Key5273024
MDR Text Key32870998
Report Number3002808486-2015-00176
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 LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2015
Is This An Adverse Event Report? Yes
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 Received11/19/2015
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

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