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

Model Number G52915

Device Problems Structural Problem (2506); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Type  Injury  

Event Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2015, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation : it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect 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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, d1, d4, g4, h4, h6 (patient and device codes).Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ/vena cava perforation, pain chest/abdominal, anxiety, depression, sleeping difficulty.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.Unknown if the reported pain chest/abdominal, anxiety, depression, sleeping difficulty 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.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received the celect filter via the right common femoral vein due to deep vein thrombosis (dvt).Patient is alleging vena cava and organ perforation.Patient notes and further alleges experiencing "occasional pain in upper abdomen/chest not associated with heart.Anxiety from not knowing the state of the ivc filter", as well as difficulty sleeping and depression.Per a computed tomography (ct) abdomen: "infrarenal ivc filter noted in place.The struts of the filter extend greater than 3 mm beyond the walls of the ivc.No penetration into adjacent organs is seen although the right posterior strut approximates the right psoas muscle and vertebral body margin.Left anterior strut abuts the third portion of the duodenum.No free fluid or hematoma formation".

• Brand Name: COOK CELECT NAVALIGN JUGULAR & 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: 13928112
• MDR Text Key: 288022897
• Report Number: 3002808486-2022-00213
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529158
• UDI-Public: (01)10827002529158(17)171120(10)E3277528
• 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,Followup
• Report Date: 07/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2017
• Device Model Number: G52915
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT
• Device Lot Number: E3277528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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: 95 KG