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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Perforation (2001); Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016032. (b)(4). Additional information provided determined that this device was manufactured by cook inc. With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc. Name and address for importer site: cook medical incorporated (cmi) (b)(4).
 
Manufacturer Narrative
(b)(4). Catalog number: unknown but referred to as a gunther tulip filter. Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057. (b)(4). Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2013. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Catalog #: unknown but referred to as a gunther tulip filter. Expiration date: unknown as lot # is unknown. Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057. Mfr date unknown as lot # is unknown. It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2013. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 2/14/2017 as follows: patient is alleging migration, vena cava perforation, device is unable to be retrieved, bleeding, organ perforation, filter incorporated into vena cava, struts protrude outside of lumen, filter strut displacement.
 
Manufacturer Narrative
(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, vena cava perforation, device is unable to be retrieved, bleeding, organ perforation. It is also alleged the filter incorporated into the vena cava, struts protrude outside of lumen, filter strut displacement. ". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Filter migration is a known potential complication of vena cava filters. Cranial (including to the heart and lungs) and caudal migrations have been reported. Among other causes, migration may be associated with filter placement in ivcs with diameters other than those specified in the instructions for use, improper deployment, deployment into clots, dislodgement due to large clot burdens, and (or) procedures that involve other devices being passed through an in situ filter. Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement. 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. There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae. E. G. Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae. In contrast, perforation of adjacent organs is reported with clinical sequelae. 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. 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.
 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6108653
MDR Text Key250671395
Report Number3002808486-2016-01417
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 Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-JUG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/10/2016
Event Location No Information
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/01/2012
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: 11/17/2016 Patient Sequence Number: 1
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