MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Death  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect platinum filter.Similar to device under.Pma/510(k): k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: after the neurosurgical procedure and the ¿off-label¿ filter placement in the superior vena cava, the clinical status of the patient (mainly respiratory and cardiac status) worsened progressively, preventing any further interventional procedures.The patient suffered persistent hypoxemia and bradycardia throughout the time in hospital and died 15 days after the filter had been placed.Patient outcome: according to the initial reporter, the patient did experience an adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: according to the article the ivc-filter was placed in the superior vc by means of a femoral access kit used for jugular access due to contraindication of anticoagulation therapy.The patient¿s condition deteriorated in the following weeks mainly due to gradual worsening of respiratory and cardiac status with persistent hypoxemia and bradycardia.The patient died 15 days after the filter implant.The exact cause of death is not stated in the report.The implantation of the ivc filter in the svc represents off-label use which is also mentioned in the case report.The fact that the implantation of the filter was achieved by means of a femoral access kit used through a jugular access site also represents off-label use of the delivery system.However, the exact cause of death is not stated in the report and consequently, it cannot be determined if the filter had any impact on the deterioration in the patient¿s health during the filter implant time and/or on the death 15 days after the filter placement.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11973112
• MDR Text Key: 255446498
• Report Number: 3002808486-2021-01327
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death