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)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Swelling (2091); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: non-healthcare professional.Investigation: 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, and tilt.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.Catalog and lot numbers 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

The following information is alleged: the patient received a gunther tulip on (b)(6) 2007 after being diagnosed with pulmonary embolus (pe).Approximately 11 years and 9 months after receiving the filter implant, the patient had a computed tomography (ct) scan of the abdomen and pelvis which revealed that the filter was tilted, embedded, and 2 of 4 primary struts perforated the wall of the inferior vena cava (ivc).The wall of the adjacent aorta was also perforated.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2007 due to bilateral pulmonary embolism (pe).Patient is alleging tilt, vena cava/organ perforation, and embedment.The patient further alleges "i have lower leg pain, swelling and abdominal pain." report from ct (computed tomography): "the ivc filter is seen within the inferior vena cava at the level of l3 and l4.A medial struts appear to penetrate through the ivc and contacts the abdominal aorta without evidence of leak at this time.".

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: pain, swelling.Unknown if the reported pain and swelling are directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 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 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 Description

Medical opinion: "the patient's ivcf is a cook gunther-tulip retrievable ivc filter positioned infrarenal at the l3 level.The filter is tilted laterally, with the filter apex in direct contact with, and possibly embedded in, the lateral caval wall just below r renal vein confluence with ivc.2 of 4 primary filter struts perforate the wall of the ivc, with the posteromedial strut impinging directly on, and possibly partially embedded in the wall of adjacent aorta.No strut fractures or missing components are identified.No caval thrombosis, wall thickening or clot within the filter.No pericaval hemorrhage.Calcified atherosclerotic plaque is present in the aorta and major branch vessels.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 allegations have been investigated: organ/vena cava perforation, embedment, tilt, pain, swelling.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.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 pain, swelling is directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 devices in lot.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.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.

• 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: 10756486
• MDR Text Key: 213715043
• Report Number: 1820334-2020-01980
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2023

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: 12/01/2009
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 1820365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 01/19/2021; 02/03/2023
• Supplement Dates FDA Received: 02/08/2021; 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2007
• 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: Male
• Patient Weight: 99 KG