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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 Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Vomiting (2144); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121629 or k121057. Investigation is still in progress. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Description of event according to article: a (b)(6) woman presented to our hospital with a 1-month history of progressive epigastric and right upper quadrant abdominal pain, nausea, anorexia, non-bloody vomiting, and loose stools. The pain was sharp, worsening over the week before presentation, and not improving with over-the-counter pain medications. Computed tomography (ct) of the abdomen and pelvis was performed, which showed mild hepatomegaly and a dilated common bile duct of 8 mm, likely due to previous cholecystectomy. It also revealed the caval filter to be in the infrarenal inferior vena cava, with the medial-most strut of the filter extending into the aorta at the level of the bifurcation and the posterior-most strut extending into the l3 vertebral body; the anterior and lateral struts appeared to extend outside the inferior vena cava into the mesentery and right psoas muscles, respectively (figures 1a-c and 2). The patient was hospitalized 2 months before admission with similar abdominal pain. During that admission, a ct scan demonstrated findings similar to the present ct results showing migration of all four struts. Patient outcome: an open surgical repair was performed involving exposure of the inferior vena cava and bilateral renal veins, with explantation of the eroding filter from the inferior vena cava. Inferior vena cava filter penetration can cause clinical sequelae and should be entertained as a cause for abdominal pain.
 
Manufacturer Narrative
(b)(4). Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook celect filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121629 or k121057. Summary of investigational findings: filter implant period is unknown. Image review confirmed a grade 3 penetration of at least three primary filter legs and possible grade 2 penetration of the fourth primary leg. Also, the legs demonstrate erosion into l3 vertebral body, penetration into aorta, and possible interaction with duodenum. The filter was surgically removed, but there is no discussion of attempted percutaneous retrieval. In this case patient was symptomatic reported as abdominal pain, but given the patient's history of pancreatitis and lupus anticoagulant syndrome with prior mesenteric venous thrombosis, it is not evident if the filter caused the abdominal symptoms, since no info regarding the resolution of symptoms following removal of filter. 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. Lot and rpn are unknown, but there is 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 article: a (b)(6) woman presented to our hospital with a 1-month history of progressive epigastric and right upper quadrant abdominal pain, nausea, anorexia, non-bloody vomiting, and loose stools. The pain was sharp, worsening over the week before presentation, and not improving with over-the-counter pain medications. Computed tomography (ct) of the abdomen and pelvis was performed, which showed mild hepatomegaly and a dilated common bile duct of 8 mm, likely due to previous cholecystectomy. It also revealed the caval filter to be in the infrarenal inferior vena cava, with the medial-most strut of the filter extending into the aorta at the level of the bifurcation and the posterior-most strut extending into the l3 vertebral body; the anterior and lateral struts appeared to extend outside the inferior vena cava into the mesentery and right psoas muscles, respectively (figures 1a-c and 2). The patient was hospitalized 2 months before admission with similar abdominal pain. During that admission, a ct scan demonstrated findings similar to the present ct results showing migration of all four struts. Patient outcome: an open surgical repair was performed involving exposure of the inferior vena cava and bilateral renal veins, with explantation of the eroding filter from the inferior vena cava. Inferior vena cava filter penetration can cause clinical sequelae and should be entertained as a cause for abdominal pain.
 
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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 Key5459678
MDR Text Key38967184
Report Number3002808486-2016-00075
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 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2016
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

Patient Treatment Data
Date Received: 02/25/2016 Patient Sequence Number: 1
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