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

Model Number G21360

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

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2020-00944.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference number.Initial reporter occupation: non-healthcare professional.Investigation the following allegations have been investigated: organ/vena cava perforation, tilt, poor blood flow, legs/arm/hand numbness, severe, headaches, pain while standing/walking, limited mobility, depression, anxiety.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 poor blood flow, legs/arm/hand numbness, severe, headaches, pain while standing/walking, limited mobility, depression, anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) devices were manufactured in the reported lot.To date, no other complaints have 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 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

Patient allegedly received an implant on (b)(6) 2014 due to deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient alleges organ perforation, vena cava perforation, and tilt.The patient further alleges poor blood flow, legs/arm/hand numbness, severe headaches, pain while standing/walking, limited mobility, depression, and anxiety.On (b)(6) 2019, report from computed tomography; ¿the ivc filter is positioned within the inferior vena cava immediately below the level of the renal veins.It has an 5 degree rightward tilt with penetration of the 2 device struts located along the left side of the device through the wall of the inferior vena cava.The tip of the more anterior penetrated strut abuts the wall of a segment of small bowel and the tip of the more posterior penetrated strut abuts the wall of the mid infrarenal abdominal aorta.There is no evidence of thrombus within the inferior vena cava, common iliac veins, external iliac veins or common femoral veins.¿.

• Brand Name: GUNTHER TULIP JUGULAR & 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: 10876146
• MDR Text Key: 217371664
• Report Number: 1820334-2020-02170
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)150501(10)4336877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: G21360
• Device Catalogue Number: IGTCFS-65-UNI
• Device Lot Number: 4336877
• 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: 06/01/2013
• 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: 143