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

Catalog Number IGTCFS-65-1-FEM-TULIP

Device Problems Device Tipped Over (2589); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); No Information (3190); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k) k172557.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2012.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

The patient received an implant on (b)(6) 2012 via the right common femoral vein due to conjunction with ts/mva.The patient alleges tilt.The patient further alleges shortness of breath, chest pain, numbness in extremities, and internal discomfort.Information has been provided indicating two filters from the same lot were placed on the same day; however, no additional event information was provided.(b)(6) 2012, per a report from implant report; ¿at this time an ivc filter was advanced through the sheath.It was then opened.However unfortunately the filter did not open.It looked to be angled.I suspect that it may be lodged within a lumbar vein branch.However it appeared to be very well anchored in this position.A second gunther tulip vena cava filter was then deployed above this level and yet below the renal veins.¿ (b)(6) 2012, per a report from xray; ¿there are 2 filter is present in the upper abdomen the more inferior of which appears angulated.¿.

Manufacturer Narrative

Investigation: the following allegations have been investigated: tilt, shortness of breath, chest pain, numbness, internal discomfort.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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, chest pain, numbness, internal discomfort are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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.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

The patient alleges blood flow issues in legs, difficulty walking, swollen legs, bipolar, anxiety, and depression.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a4, b5, b6, b7, h6.Investigation: the following allegations have been investigated: blood flow issues in legs, difficulty walking, swollen legs, bipolar, anxiety, depression.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported blood flow issues in legs, difficulty walking, swollen legs, bipolar, anxiety, depression is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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.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 NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 10874167
• MDR Text Key: 217300586
• Report Number: 3002808486-2020-01083
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• 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: 03/30/2023

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: 11/03/2014
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 01/19/2021; 03/17/2023
• Supplement Dates FDA Received: 02/12/2021; 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: 95 KG