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

Model Number G52914

Device Problem Structural Problem (2506)

Patient Problems Pain (1994); Perforation of Vessels (2135); Distress (2329); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Type  Injury  

Event Description

Patient allegedly received a celect inferior vena cava (ivc) filter on (b)(6) 2011 via the right groin to prevent deep vein thrombosis (dvt).Patient is alleging vena cava perforation.Patient notes and further alleges experiencing pain, mental anguish, emotional distress, physical impairment and fear.

Manufacturer Narrative

The previous mdr was submitted by william cook (b)(4) under manufacturer report reference number 9680654-2021-00008.It has been determined that the report should have been submitted under william cook (b)(4).With the submission of this initial report, william cook europe informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in g8 of this initial medwatch report.Blank fields on this form indicate the information is unknown or unavailable.Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: vena cava perforation, pain, mental anguish, emotional distress, physical impairment, fear.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This 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).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported pain, mental anguish, emotional distress, physical impairment, fear is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

• Brand Name: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13457547
• MDR Text Key: 289329447
• Report Number: 3002808486-2022-00062
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)131028(10)E2665407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: G52914
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2665407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 68 KG