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

Model Number G34502

Device Problems Difficult to Remove (1528); Structural Problem (2506)

Patient Problems Arrhythmia (1721); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Reporter occupation: other health care professional.Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: patient experience extreme shortness of breath, hypertension and rapid heart beat right after having surgery for the filter placement.The device was removed as a result of her complications and the device was embedded in the wall.Two attempts were made to remove the device, first attempt was on (b)(6) 2020 and the cardiologist was having complications removing the device so a cardiac catheter was inserted and the patient reports being transferred to the hospital.The second attempt for removal was on (b)(6) 2020 by the interventional radiologist and the removal was successful.However, the physician told the patient the surgery to remove the filter was very complicated because the filter was embedded.Patient outcome: patient reports after one week of having the device removed she is now feeling much better.

Manufacturer Narrative

Manufacturers ref# pr313532 summary of investigational findings: patient reports experiencing extreme shortness of breath, hypertension and rapid heartbeat right after having surgery for the filter placement.The filter was removed as a result of her complications.Because the filter was embedded in the wall it was difficult to remove and required two attempts to remove it.Patient reported feeling much better one week after removal.It was assessed that because no non-conformances were detected, 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 nonconforming product exists in house or in field.According to instruction for use potential adverse events that may occur include, but are not limited to, the following: arrhythmia there are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information an exact cause for the reported event cannot be established.However, arrhythmia is a known potential adverse event for filter placement.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: 10815109
• MDR Text Key: 215486070
• Report Number: 3002808486-2020-01022
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230609(10)E3989523
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3989523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention