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

Model Number G34505

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Great Vessel Perforation (2152); Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510(k): k171712.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: a female patient underwent a filter implant on (b)(6) 2015 in which the cook celect platinum navalign uniset vena cava filter set, g34505, was used.The patient presented for an unrelated issue to the hospital on (b)(6) 2019 which the physician ordered a ct scan.During the ct scan it was discovered that the tip of the filter had fractured and separated and penetrated the aorta.One leg perforated the left renal, one perforated the right kidney, and one is in the l4 vertebral body.No removal procedures to be done related to this however, due to patients overall general health status.Patient outcome.The filter and broken legs remain in the patient.Due to patients overall general health the device will not be removed.The product did not contribute to the need for additional procedures and it had no adverse effects on the patient.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description only.No product was returned and no imaging was provided.Therefore, based on the limited information provided it would be inappropriate to speculate at what may or may not have caused the filter to fracture and the primary filter legs to perforate the aorta, the left renal, the right kidney, and the l4 vertebral body approx.4 years after filter placement.However, it is noted that the fracture as well as the perforations were discovered during ct scan, when the patient presented at the hospital for an unrelated issue and that there are no removal procedures to be done due to patients overall general health status.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that non-conforming product exists in house or in field.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: COOK CELECT PLATINUM NAVALIGN UNISET 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: 9882241
• MDR Text Key: 185665920
• Report Number: 3002808486-2020-00367
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)180831(10)E3362007
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3362007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening