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

Model Number	G33017
Medical Device Problem Codes	Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person) not provided, information provided by (b)(6).Occupation: non-healthcare professional.Investigation: 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.Rpn/lot is unknown, however, 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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It is alleged that "patient received a cook tulip filter.Patient is alleging filter perforation of organ.Hospital and medical records have not been provided.".
Event or Problem Description
Additional information received alleges that the patient experienced multiple perforations of the inferior vena cava (ivc) by the filter.Multiple perforating struts either abut or perforate adjacent structures.
Additional Manufacturer Narrative
Additional information: 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 allegation has been investigated: vena cava perforation.The additional information regarding vena cava perforation does not change the previous investigation results for organ perforation.A total of 20 devices were manufactured in the reported lot.To date, one additional complaint has been reported against this lot (5308523).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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Patient is alleging vena cava and organ perforation.Patient notes and further alleges experiencing anxiety, worry, fear, limited physical activity, per a computed tomography (ct) abdomen/pelvis: "findings: the superior tip of an inferior vena cava filter is at the level of the complex of the inferior vena cava and right renal vein.The superior tip of the filter is tilted 14 degrees laterally and is either apposed to the right anterolateral ivc wall or extending slightly beyond its margin (series 2, images 57-59).There is perforation of 2 filter struts.One is at the 3 o'clock radian position on the axial images (series 2, image 70) with its tip in the aortocaval space and the other at the 5 o'clock position with its tip imbedded in the l3 vertebral body (images 68-71).The remaining struts appear to be immediately adjacent to the margin of the inferior vena cava, likely representing tenting.No abnormal soft tissue mass or fluid collection is seen in the pericaval or periaortic region.No filter fracture is seen.No obvious thrombus is appreciated on this unenhanced study".
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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, anxiety, worry, fear, limited physical ability.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.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.Unknown if the reported worry, fear, limited physical ability is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 devices were manufactured in the reported lot.To date, one additional complaint has been reported against this 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 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.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov IN 47404
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov, IN 47404 ; 8123392235
• MDR Report Key: 14444276
• Report Number: 1820334-2022-00840
• Device Sequence Number: 12366798
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)170901(10)5308523
• Combination Product (Y/N): N
• PMA/510(K) Number: K072240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: G33017
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 5308523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 10/18/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/10/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female
• Patient Weight: 68 KG