MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G53229
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Pain (1994); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous mdr was submitted by william cook europe under manufacturer report reference# 3002808486-2018-00926.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc.Informs that all future submissions regarding this complaint will be handled under manufacturer report reference# 1820334-2018-02736.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
This additional information received on (b)(6) 2018 as follows: patient allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to pulmonary embolism, deep vein thrombosis.Patient is alleging device is unable to be retrieved, embedded and blood transfusion without further explanation.Patient further alleges to have experienced pain and injuries.Retrieval attempt (peripheral intravenous access) (b)(6) 2010, but was unsuccessful.
Additional Manufacturer Narrative
Additional information - investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.The following allegations have been investigated: thrombus.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.
Event or Problem Description
No additional information provided at this time.
Additional Manufacturer Narrative
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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
Event or Problem Description
No additional information provided at this time.
Event or Problem Description
No additional information provided at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information.Investigation ¿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 'tulip - unable retrieved, blood transfusion, embedded, pain, injuries'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.Unknown if the reported pain/discomfort is directly related to the filter.Unknown if the reported need for blood transfusion or injuries are directly related to the filter and unable to identify corresponding failure mode(s) at this time.No relevant notes on neither device or lot number.No other complaints on lot.Product is manufactured and inspected according to specifications.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.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.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7847180
• Report Number: 1820334-2018-02736
• Device Sequence Number: 1536798
• Product Code: DTK
• UDI-Device Identifier: 00827002532298
• UDI-Public: (01)00827002532298(17)160301(10)U2349073
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K043509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: G53229
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2349073
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 12/20/2018; 05/30/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/30/2018; 01/17/2019; 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 112