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

Model Number G34502

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Pma/510(k) k171712.Investigation is still in progress.

Event Description

"celect pt punctured sheath while traversing the tortuous iliac vein.(b)(6) male ivcf placement for failed anticoagulation therapy." placed another filter via internal jugular vein.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the complaint report states that a celect platinum filter punctured the sheath during a femoral approach procedure.Per image/video review, only the inferior aspect of the ivc and central portion of the iliac vein are seen.This demonstrates extreme tortuosity of the iliac system extending into the ivc.Ivc filter deployment sheath makes a nearly 90-degree bend at the confluence of the iliac veins into the ivc, mirroring that of severe atherosclerotic calcifications outlining the aorta and iliac artery.There is likely a compound angle as the iliac vein and ivc usually dives deeper into the pelvis, this additional angulation is not appreciated on this single image.As explained, once the introducer dilator of the sheath was removed, the sheath may have kinked or created an acute bend at the apex of angulation.When attempting to advance the ivc filter through this area, significant resistance would have been encountered in advancement of the filter.The ifu for the ivc filter states "excessive force should not be exerted to advance the filter through the delivery system." if the filter was able to be pushed through the wall of the sheath, this could be defined excessive of force.Using fluoroscopy while advancing the filter through the tortuous sheath, likely would have decreased the chance of penetration, as the kink would be visable.The patient did experience some discomfort during filter retrieval from the groin area but the device was removed in its entirety.The device history record was reviewed with no evidence to suggest that this device was not manufactured according to specifications.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.

Event Description

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

• 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: 8502735
• MDR Text Key: 141593768
• Report Number: 3002808486-2019-00414
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)220211(10)E3821705
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/11/2022
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3821705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Distributor Facility Aware Date: 03/27/2019
• Device Age: 1 MO
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR