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

Catalog Number UNKNOWN

Device Problems Inadequate Filtration Process (2308); Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2008 and underwent a computed tomography (ct) scan, approximately 11 years and 2 months later, that revealed perforation of the ivc wall and the adjacent aorta.In addition to perforation, the filter was found to be tilting approximately 16 degrees causing the tip to abut the anterior vena cava wall.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional investigation: the reported allegations have been investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation 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 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.

Manufacturer Narrative

The following fields were updated per additional information received: a2, a4, b5, b6, b7, annex e, annex a, annex g, annex b, annex c, annex d, and h6.Investigation the following allegations have been investigated: pulmonary embolism, organ/aorta perforation, leg swelling, shortness of breath (sob), limited activity.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.The additional information regarding organ/aorta perforation does not change the previous investigation results for vena cava perforation.Unknown if the reported leg swelling, shortness of breath (sob), limited activity 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 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 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

Patient allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to post pulmonary embolism (pe).The patient alleges tilt, vena cava and organ perforation.The patient further alleges leg swelling, shortness of breath (sob), limited activity, and pe.15mar2019, per a report from computed tomography; ¿impression: ivc filter has 16 degree anterior tilt with tip abutting the anterior ivc wall, 4 struts perforating the ivc, 1 extending into the aorta.¿.

• 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: 13949284
• MDR Text Key: 288184584
• Report Number: 1820334-2022-00485
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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: 06/27/2022
• 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: Male
• Patient Weight: 104 KG