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

Model Number G33016

Device Problems Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2017-01722.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 number referenced in this initial medwatch report.Occupation: non-healthcare professional.(b)(4).Investigation is reopened due to additional information provided.The following allegations have been investigated: embedded, thrombosis, occluded iliacs, pain, anxiety depression.The reported allegations have been further investigated based on the information provided to date.The current verbiage has been added to further investigate the previously alleged embedment.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.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.Unknown if the reported pain, anxiety and depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported lot.To date, one other complaint has been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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 includes information known at this time.A follow up report will be submitted should additional information become available.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.Only if investigation is done already.

Event Description

Patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to deep vein thrombosis (dvt).Patient alleges device tilt and embedded filter.Patient notes and further alleges experiencing "severe pain resulting in a trip to the emergency room which revealed that there were blood clots being blocked by the ivc filter that caused blood clots in my stomach and down both legs".Patient additionally notes depression and anxiety.Device was successfully retrieved on (b)(6) 2016.Per the (b)(6) 2016 ivc (inferior vena cava) filter removal: "angiogram revealed no thrombus within the ivc or within the filter.The filter was tilted and the apex was within the walls of the ivc.We now had through and through access around the hook.We then advanced the 6-french guide and the 12-french sheath and were able to successfully capture the hook and the entire filter.The guide containing the filter was removed.He then did a venogram which demonstrated no hemorrhage".

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9583139
• MDR Text Key: 188496734
• Report Number: 1820334-2020-00102
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)140901(10)2830769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2830769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 120