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

Catalog Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Bowel Perforation (2668)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Auyang, p., et al., "examining outcomes and causes of symptomatic long-term indwelling inferior vena cava filters", journal of vascular surgery, 2018, vol.67, no.6, e158-e159.Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.(b)(4).Investigation is still in progress.

Event Description

Description of event according to article: in the abstract authored by auyang et al.A review was completed of 15 patients (mean age 52.8) of whom 3 patients received treatment with a celect filter.3 male patients listed in the abstract each received a celect filter and each patient experienced pain.A male patient (age (b)(6)) experienced structure involvement in the duodenum, aorta and gi bleed and abdominal pain with symptoms occurring for 24 months total.Filter was removed by open surgery.Auyang et al.State that the aim of the study was to "correlate the symptoms to the location of the ivc filter struts and to examine outcomes" (2018, p.E158).The authors stated that the etiology of pain was determined to be directly correlated the area where the ivc struts protruded in the patient.Patient outcome: the patient experienced a resolution to the pain.The filter was removed by open surgery.

Event Description

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

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).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 the information provided in article.A male patient experienced structure involvement in the duodenum, aorta and gi bleed and abdominal pain with symptoms occurring for 24 months total.Filter was removed by open surgery and the patient experienced resolution to his pain.No product was returned and no imaging was provided.Therefore, it would be inappropriate to speculate at what may or may not have caused the filter to perforate the ivc and the patient to experience structure involvement in the duodenum, aorta and gi bleed and abdominal pain with symptoms occurring for 24 months total.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, 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.Very limited information was provided, but immediately there is no evidence to suggest that this celect filer was not manufactured according to specifications and nothing indicates that it 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.

• 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: 7994563
• MDR Text Key: 124669797
• Report Number: 3002808486-2018-01235
• 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,literatur
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 34 YR