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

Model Number G33016

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2020-00284.Occupation: non-healthcare professional (b)(4).Investigation: the following allegations have been investigated: organ/ vena cava (vc) perforation, tilt, nausea, itching, swelling, abdominal/leg pain, limited physical activity.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 nausea, itching, swelling, abdominal/leg pain, and limited physical activity 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, two 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 current controls.There is 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 via the right common femoral vein due to post deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging organ/vena cava perforation and tilt.The patient further alleges nausea, itching around the insert which cause leg pain accommodated with swelling, abdominal pain, and limited physical activity.(b)(6) 2019, per a report from computed tomography (ct); ¿vasculature: an ivc filter is identified, with the apex at the left renal vein confluence with the ivc.There is 15 degree leftward tilt of this ivc filter.No stress fracture is seen.A posterior strut extends 4 mm peripheral to the ivc wall in the retroperitoneal fat.The medial strut abuts the right aortic wall.Ivc is unremarkable as is the aorta.¿ original: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2014.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: 9883692
• MDR Text Key: 196437353
• Report Number: 1820334-2020-00691
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330167
• UDI-Public: (01)10827002330167(17)170601(10)5113284
• 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: 03/26/2020

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: 06/01/2017
• Device Model Number: G33016
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 5113284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 84