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

Catalog Number UNKNOWN

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Patient and device code: no information regarding the event has been provided.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2003.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

No additional information to report at this time.

Manufacturer Narrative

H10: 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.Vena cava wall penetration/perforation has been reported and 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).Unknown if the reported ben strut is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot# are unknown, but the filter 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.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) 2003 via the femoral vein due to deep vein thrombosis (dvt).Patient alleges tilt, organ perforation and bent strut.Per abdominal ct, dated (b)(6) 2018, "evidence for an inferior vena cava filter with the cephalad apex approximately 1.8 cm from the lowest renal vein.There is significant leftward tilt of the cephalad apex of the filter which penetrates the inferior vena cava and extends approximately 4 mm into the adjacent adipose tissues along the left anterolateral margin of the inferior vena cava.There is evidence for perforation of at least two of the struts along the right anterolateral aspect and along the right posterolateral aspect with extension into the adjacent adipose tissues anteriorly and into the anterior longitudinal ligament of the spine posteriorly by approximately 3 mm respectively.There is question of a bent strut within the upper portion of the filter anteriorly.".

Manufacturer Narrative

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.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8337153
• MDR Text Key: 136114745
• Report Number: 1820334-2019-00393
• 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,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• 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: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 104