MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the reported allegations have been investigated based on the information provided to date.The following allegations have been investigated: organ/vena cava perforation, tilt, and "deformed" filter.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 deformed filter is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.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 following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter in 2010 and underwent a computed tomography (ct) scan of the abdomen/ pelvis after experiencing chest pain.The radiology report from this ct report indicated simply that a[n] "[i]nfrarenal inferior vena caval filter present." the patient was allegedly not given indication that the filter could be causing any issues.Approximately 1 year and 9 months after this ct scan, a later review of imaging from this ct scan occurred.This later review indicated that the patient was experiencing a 16 millimeter (mm) vertebral [perforation] and between 13-14 mm mesenteric perforation.This review also indicated that the filter had perforated the ivc, tilted with the apex of the filter against the ivc wall and was deformed, possibly fractured.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant in 2010.Patient is alleging tilt, organ and vena cava perforation, and fracture.Patient alleges "back pain, shortness of breath (sob), abdominal pain." per computed tomography (ct) report, "filter position: below the level of the renal veins." "filter tilt: yes" "filter penetration: yes" "the filter tilted to anterior with its proximal cone against the ivc wall." "the filter is in the distal ivc with its legs sticking through the ivc bifurcation." "the is a stent in each of the common iliac veins extending the distal ivc." "the anterior right strut penetrates 14 mm through the ivc wall." "the anterior left strut penetrates 13 mm through the ivc wall." "the posterior right strut penetrates 16 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes." "the posterior left strut penetrates 13 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes." "the filter is deformed.It is hard to tell if the filter is fractured because the exam is of the entire abdomen, pelvis, and legs and in order to evaluated the filter the images have to be magnified which degrades them.".

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 following allegations have been investigated: fracture, vertebra perforation, back pain, shortness of breath (sob), abdominal pain.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.The additional information regarding vertebra perforation does not change the previous investigation results for vena cava perforation.Unknown if the reported back pain, shortness of breath (sob), abdominal pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog 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 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: UNKNOWN
• 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: 15931334
• MDR Text Key: 304962437
• Report Number: 1820334-2022-01815
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 125 KG