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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 Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 11/05/2012
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(4). Catalog#: unknown but referred to as a cook günther tulip filter. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2012, [pt] had a cook gunther tulip ivc filter implanted pursuant to a doctor's order. On or around (b)(6) 2013 [pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable. A second filter was implanted on (b)(6) 2012 due to the first filter failing to deploy ((b)(4)). Pt alleges migration, tilt, device unable to be retrieved, failed deployment, failure to dislodge from sidewall of ivc, embedment. Attempted filter retrievals were performed on (b)(6) 2012 and (b)(6) 2013. Pt allegedly received two filter implants on (b)(6) 2012 via the right common femoral vein to prevent deep vein thrombosis during knee surgery. The first gunther tulip filter failed to deploy and the filter was left in the soft tissue behind the vein. No filter retrieval will be attempted as the filter hook is embedded in the soft tissue. ((b)(4)). Radiographic findings of introduction of first filter according to medical records ". The tulip filter was then inserted under fluoroscopy. It was positioned using road mapping up to the midportion of l2 and was deployed. This resulted in incomplete deployment of the device which remained almost entirely constrained. Contrast imaging in the ap view demonstrates it to be in the center of the flow lumen. Low pressure angioplasty was attempted resulting in mild discomfort and therefore a lateral image was performed confirming the position of the device in the soft tissue space behind the vena cava. Fortunately, this image reveals no significant extravasation into the soft tissue space. The device was left in place here as the retrieval hook is within the soft tissue and would no able to be grasped from above. The feet of the device are just barely extending into the vena cava and do not impede flow. The device itself appears to be obturating what must be entry into the soft tissue space and effectively achieving hemostasis. The sheath and guidewire were used to advance into the vena cava and confirmatory venography was performed with the flush catheter at the level of the left renal vein". Patient outcome: as a direct and proximate result of these injuries, [pt] has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering and loss of enjoyment of life, and [pt] has otherwise been damaged in a personal and pecuniary nature. " alleged that "[pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7661828
MDR Text Key113247638
Report Number3002808486-2018-00805
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 OTHER CAREGIVERS
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date06/28/2018
Event Location No Information
Date Manufacturer Received08/07/2018
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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