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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-TULIP
Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Unintended Movement (3026)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Unspecified Infection (1930); Respiratory Distress (2045); Swelling (2091); Disability (2371)
Event Date 01/22/2016
Event Type  malfunction  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Name and address for importer site: (b)(4). Corrected data based on new information received: adverse event to product problem, serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 09/01/2017 as follows: patient received an implant on (b)(6) 2013 via the right internal jugular vein due to pulmonary embolization. Patient experiences embedment. Patient is alleging device migration, tilt, that the device is unable to be retrieved, severe pain, palpitations and chest pain, onset of shortness of breath and difficulty breathing when lying down. Retrieval was attempted on (b)(6) 2016 and successful device retrieval on (b)(6) 2016.
 
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'migration, tilt, difficult to retrieve, pain, palpit & chest pain, shortness of breath'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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. Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period. Unknown if the reported palpitations, chest pain, sob (shortness of breath), difficulty breathing laying down is directly related to the filter and unable to identify corresponding failure mode(s) at this time. 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.
 
Manufacturer Narrative
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Manufacturer Narrative
(b)(4). Age/date of birth) unknown as information was not provided. Weight) unknown as information was not provided. Date of event) unknown as information was not provided. Brand name) unknown as information was not provided. Lot#: unknown as information was not provided. Catalog#: unknown but referred to as a cook günther tulip filter. Expiration date: unknown as lot# is unknown. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. Device manufacture date) unknown as lot# is unknown. Investigation is still in progress.
 
Event Description
Description according to complainant: it is alleged that "[pt] on or about (b)(6) 2013, [pt] was implanted with a cook gunther tulip filter at (b)(6). In late 2015, [pt] began experiencing significant chest pain, swelling in her legs, and shortness of breath. On or about (b)(6) 2016, [pt] presented to the hospital to have the cook filter removed. The doctor attempted to remove the filter, but the filter was embedded and had migrated from its original location. The doctor was unable to remove the filter. [pt] was advised to see a specialist in chicago to remove the embedded cook filter. On or about (b)(6) 2016, [pt] had her cook filter removed after a long surgery and several failed attempts to remove the filter. On or about (b)(6) 2016, [pt] was rushed to her local hospital with severe chest pain. She was informed that she had an infection around her heart likely caused from the cook filter and the surgery to remove the embedded filter. [pt] was hospitalized for about a week to recover from this infection. " patient outcome: "[pt] has continued to suffer symptoms and physical limitations, and she requires on-going medical care, as a result of the multiple surgeries needed to remove the cook filter" hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog#: unknown but referred to as a cook günther tulip filter. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057 summary of investigational findings: no device, imaging studies or hospital or medical records have been available. Consequently, based on very limited information, it is not possible to comment on the alleged filter migration and failed retrieval attempts approximately 2 years after implant of a tulip filter nor on the infection diagnosed 2 days after the filter was removed by surgery. Further, it is not possible to comment on the alleged "significant chest pain, swelling in her legs, and shortness of breath" and "[pt] has continued to suffer symptoms and physical limitations, and she requires on-going medical care". Under normal conditions, i. E. 15 mm 30mm). Manipulation in the area of the filter implant or a blood clot captured inside the filter may cause migration or contribute to changes in the filter configuration and placement. 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. Based on the available information it is unknown which retrieval techniques were used during the reported retrieval attempts. Rpn and lot number were not provided, 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 according to complainant: it is alleged that "[pt] on or about (b)(6) 2013, [pt] was implanted with a cook gunther tulip filter at (b)(6). In late 2015, [pt] began experiencing significant chest pain, swelling in her legs, and shortness of breath. On or about (b)(6) 2016, [pt] presented to the hospital to have the cook filter removed. The doctor attempted to remove the filter, but the filter was embedded and had migrated from its original location. The doctor was unable to remove the filter. [pt] was advised to see a specialist in (b)(6) to remove the embedded cook filter. On or about (b)(6) 2016, [pt] had her cook filter removed after a long surgery and several failed attempts to remove the filter. On or about (b)(6) 2016, [pt] was rushed to her local hospital with severe chest pain. She was informed that she had an infection around her heart likely caused from the cook filter and the surgery to remove the embedded filter. [pt] was hospitalized for about a week to recover from this infection. " patient outcome: "[pt] has continued to suffer symptoms and physical limitations, and she requires on-going medical care, as a result of the multiple surgeries needed to remove the cook filter. " hospital and medical records have been requested but not yet provided.
 
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Brand NameGUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
dk-4632 bjaeverskov, IN 4632
DA   4632
8004574500
MDR Report Key5696712
MDR Text Key249337339
Report Number3002808486-2016-00367
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 Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/25/2016
Event Location No Information
Date Manufacturer Received02/15/2018
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: 06/03/2016 Patient Sequence Number: 1
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