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

Model Number G33016

Device Problems Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Headache (1880); Pain (1994); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by (former manufacturer) under manufacturer report reference number (b)(4).Additional information provided determined that this device was manufactured by cook inc (cinc).With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced of this initial medwatch report.Blank fields on this form indicate the information is unknown or unavailable.Occupation: (b)(6).Investigation: the following allegations have been investigated: vena cava (vc) perforation, tilt, headache, leg pain.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported headache and leg pain are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4).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.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right femoral vein due to morbid obesity.Patient is alleging device tilt and vena cava perforation.Patient notes and further alleges experiencing "from time to time, i get very bad headaches and my right leg hurts", per the (b)(6) 2018 ct abdomen: "the inferior vena cava is difficult to evaluate due to the lack of contrast and lack of intra-abdominal fat.However, the ivc filter is tilted medially.The apex appears to perforated through the medial wall of the ivc.The tip is located below the left vein although it is above the level of the right renal vein.The anterior, lateral, medical and posterior struts appear to lie outside the margins of the vein suggesting perforation.The lateral strut appears to perforate by 2.9 mm.The posterior strut also appears to have perforated for a length of a few millimeters but this is difficult to quantify.The anterior and medial struts have just perforated the wall of the ivc without clear fat planes.There is no penetration of the aorta or adjacent organs".Original: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2011.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

• 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: 10946469
• MDR Text Key: 219540796
• Report Number: 1820334-2020-02240
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)140801(10)2820001
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2820001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2011
• 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: 95