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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Implant date: (b)(6) 2008, explant date: (b)(6) 2017.User facility voluntary medwatch report form 3500a reference: (b)(4).(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Per the medwatch report: "ivc filter was placed at an outside facility about nine (9) years ago.Patient had reportedly underwent two (2) prior failed removal attempts.Ivc filter was known to be fractured since about two (2) years ago.Reportedly, the main portion of the filter was now able to be removed, however a small portion of a fractured wire remains.No reported patient harm.Patient made aware and will be seen in follow up as recommended by the physician." incident occurred during an inferior vena cava (ivc) filter retrieval of a gunther tulip filter.Additional information regarding the fractured wire, retrieval, and patient outcome has been requested, but is not available at this time.

Manufacturer Narrative

Evaluation - investigation: it was reported, ¿the gunther tulip ivc filter was placed at an outside facility on or about march, 2008.Patient had reportedly experienced 2 prior failed removal attempts.Ivc filter was known to be fractured since about 2 years ago.Reportedly, the main portion of the filter was finally able to be removed.A small portion of a fractured wire remained.No reported patient harm.Patient made aware and will be seen in follow up as recommended by the physician.¿ the günther tulip filter is used for the prevention of recurrent pulmonary embolism via placement in the vena cava.There is no information regarding the deployment of the filter.There is no information indicating the device may have migrated over time.There is no information regarding whether the patient experienced pain or discomfort.There is no information indicating whether the filter hook embedded into the caval wall or if there was any observed in-growth.There is no information regarding whether the filter penetrated or perforated the caval wall.Imaging has been requested.At this time, clinical assessment cannot eliminate any possible causes for this event such as product handling, user technique, medical procedure, human anatomy, device failure, or manufacturing related causes.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that filter fragment embolized into the heart or lung may be safely retrieved.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.No evidence to suggest that this filter was not manufactured according to specifications and there were no indications that it did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.A definitive root cause could not be determined.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7026659
• MDR Text Key: 91892682
• Report Number: 1820334-2017-03691
• 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: consumer,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 54 YR