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

Catalog Number IGTCFS-65-JUG

Device Problems Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Discomfort (2330); Numbness (2415); Cognitive Changes (2551); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2021-01079.However 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 reference in this report.It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog # is unknown but referred to as gunther tulip.Occupation: non-healthcare professional.Catalog number and lot number are unknown, however, the alleged tulip 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

Original: it is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2006, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant via the right internal jugular vein after venous thrombosis(vt)/pulmonary embolism (pe) diagnosis.Patient is alleging device tilt and mesenteric perforation.Patient notes and further alleges experiencing "shortness of breath, numbness in the extremities, impaired cognitive function, back pain, internal discomfort and embedded filter".Per a computed tomography (ct) abdomen without contrast: "the ivc filter is normally located within the ivc with the tip 30 mm inferior to the renal vein.Angle of tilt: 8 [degrees] to the left.Struts: the ivc filter struts show 3.5 mm of extension through the inferior vena cava wall.There is no organ extension.No fracture.Ivc caliber: the inferior vena cava shows no evidence of fixed focal stenosis".

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ/vena cava perforation, embedment, tilt, shortness of breath, extremity numbness, pain, discomfort, impaired cognition.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 shortness of breath, extremity numbness, pain, discomfort, impaired cognition is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 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 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.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: physical limitations.Unknown if the reported physical limitations is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) 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 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.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient is alleging vena cava perforation.Patient notes and further alleges experiencing physical limitations.

• 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: 11677842
• MDR Text Key: 245767770
• Report Number: 1820334-2021-01143
• Device Sequence Number: 1
• Product Code: DTK
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2008
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 1575967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2005
• 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 Sex: Female
• Patient Weight: 175 KG