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); Perforation of Vessels (2135); Anxiety (2328); Depression (2361)

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: pulmonary embolism, vena cava perforation, tilt.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.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.The alleged tulip 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 medwatch report will be submitted if additional relevant information becomes available.

Event Description

Patient allegedly received an implant via right internal jugular vein due to left popliteal deep vein thrombosis (dvt) per implant operative report.Per a computerized tomography (ct) scan of the chest dated (b)(6) 2006, ¿right lower lobe segmental and subsegmental pulmonary embolus in the posteromedial right lower lobe pulmonary artery.It is uncertain whether this represents an acute pulmonary embolus or embolus that occurred prior to placing the ivc filter.¿ per a ct of the abdomen dated (b)(6) 2019 (reading 1), ¿ivc filter with: a 20-degree tilt of apex; 4 mm mesenteric perforation; no fracture, migration or stenosis.Cook tulip filter.¿ per a ct of the abdomen dated (b)(6) 2019 (reading 2), ¿all 4 inferior struts extend outside the wall of the ivc filter or a distance of 3¿4mm.No sign of adjacent organ fracture.No sign of hemorrhage or mass effect.Nothing to suggest ivc thrombosis.The apex of the filter lies within the midportion of the ivc.A slight apex tilt to the left is noted with the angle measuring 8 ¿ degrees.No evidence for ap tilt.¿.

Event Description

Patient is alleging device tilt, vena cava perforation and pulmonary embolism (pe) in the right lobe after filter placement.Patient notes and further alleges experiencing "fear and anxiety the filter will continue to tilt and perforate causing further internal damage that will eventually result in death", two suicide attempts (b)(6) 2017, (b)(6) 2018) "due to deep depression and anxiety from fear of filter".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b7, h6 (patient codes).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: fear, anxiety, suicide attempts, depression.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported fear, anxiety, suicide attempts, and depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.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 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
• MDR Report Key: 10096272
• MDR Text Key: 196786146
• Report Number: 1820334-2020-01003
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• 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
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening