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

Model Number G33017

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

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by (b)(4) 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 in this initial medwatch report.Reporter occupation: non-healthcare professional investigation: the following allegations have been investigated: organ/vena cava perforation, tilt, abdominal swelling, limited mobility, fear.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 abdominal swelling, limited mobility, fear are directly related to the filter and unable to identify a corresponding failure mode at this point in time.12 devices in lot.No relevant notes on work order.The 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.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) 2011 via the right internal jugular vein due to post deep vein thrombosis (dvt).The patient alleges tilt, vena cava perforation, and organ perforation.The patient further alleges abdominal swelling, limited mobility, and fear.On (b)(6) 2011, per a report from implant report; ¿the filter was released at the level of l2 with full deployment of the legs.Initial deployment was slightly tilted to the left, but redeployed with a satisfactory position.¿ on (b)(6) 2019, per a report from computed tomography: "there is a gunther tulip type ivc filter in place in the inferior vena cava.The filter is tilted 9° towards the right side but parallel to the long axis of the ivc.All 4 of the larger metallic struts project outside of the ivc wall by up to 1 cm in length and 5 mm in the transverse plane.The left-sided struts protrudes into the right lateral wall of the abdominal aorta is a region of focal disruption of the aortic mural calcification"."an anterior strut contacts the posterior surface of the transverse duodenum.The upper tip of the filter partially crosses the confluence of the ivc and renal veins.No broken fragments are identified".

• Brand Name: GUNTHER TULIP JUGULAR 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: 12391704
• MDR Text Key: 268923557
• Report Number: 1820334-2021-02086
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)140701(10)2791374
• 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
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2791374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: 73