MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-FEM-CELECT-PT

Device Problem Device Issue (2379)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).D4) catalog# is unknown but referred to as cook celect filter.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.G5) since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: difficulty experienced with celect platinum ivc filter.Patient has had an ivc filter inserted at the via the right common femoral vein approach.The patient has been discharged with the filter insitu.The patient has re-presented to hospital after six weeks with spontaneous haemorrhage around the vena cava at the location of the ivc filter.This has been determined by ct.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Catalog# igtcfs-65-2-fem-celect-pt.Name and address for importer site: (b)(4).Investigation is still in progress.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description only.No images were provided and based on the information provided it would be inappropriate to speculate at what may or may not have led to the reported "spontaneous haemorhage around the vena cava at the location of the ivc filter" approximately six weeks after filter placement.It is noted that the complainant has not directly stated that the problems were a direct result of the filter insertion and also, it is unknown, if the filter was retrieved.However, the complaint will be reopened, in case further information is received.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.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6709842
• MDR Text Key: 79889736
• Report Number: 3002808486-2017-01528
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

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: IGTCFS-65-2-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/28/2017
• Device Age: 2 MO
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 08/28/2017; 12/11/2017
• Supplement Dates FDA Received: 09/13/2017; 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening