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

Catalog Number UNKNOWN

Device Problems Break (1069); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Bowel Perforation (2668)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).No code available for bowel perforation.(b)(4) - type of investigation not yet determined.Corrected data compared with medwatch report mw5078870: product problem, hospitalization, celect, cook, inc (b)(4).Model# celect ivc filter, lot# unknown.Investigation is still in progress.Mw5078870.(b)(4).

Event Description

Description of event according to initial reporter: "a (b)(6) male, with a celect filter placed at an unknown date 9 years ago.Broken, one full leg migrated and apparently projecting through the ra into the lung effectively skewering it with some pericardial effusion.In abdomen one leg was skering duodenum with hematoma.Patient had abdominal pain.The filter was removed (b)(6) 2018 and we are assessing what to do about the migrated leg as it does appear to be "symptomatic" with the pericardial effusion.He may well need open heart surgery.Patient was discharged and awaiting follow-up cta.Information received from medwatch report mw5078870: "had cook celect filter placed in ivc 8 years ago after polytrauma.Presented in 2018 with abdominal pain.Ct scan showed strut of filter penetrated duodenum with intramural hematoma.A single fractured strut was found within pericardiac tissues surrounding the right atrium.Extending into the adjacent right lung.Filter was removed from ivc on (b)(6) 2018 using endovascular techniques.Patient will undergo additional testing and evaluation to determine treatment plan for remaining strut in pericardial tissues/lung.Patient outcome: patient is awaiting cta and follow-up.Patient was discharged.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Summary of investigational findings: investigation is based on event description only.No product was returned and no imaging was provided.Therefore, based on limited information provided it would be inappropriate to speculate at what may or may not have caused the filter to fracture approx.9 years after filter placement with one fractured leg migrating and apparently projecting through ra into the lung and one other leg skewering duodenum with hematoma.It is noted that the filter was removed and that it is to be decided "what to do about the migrated leg as it does appear to be "symptomatic" with the pericardial effusion.He may well need open heart surgery.Patient was discharged and awaiting follow-up cta." 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.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 medical will continue to monitor for similar events.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7804182
• MDR Text Key: 117829956
• Report Number: 3002808486-2018-00955
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/06/2018
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR