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

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Continuation of medical products: ddbb1d4 icd, 407645, lead; 6935m55, lead.Implanted (b)(6) 2013.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

Description of event according to initial reporter: a female patient had a cook celect vena cava filter implanted approximately 10 years prior due to trauma sustained from a motorcycle accident.Upon retrieval the physician noted that one leg had fractured and embedded into the intima layer of the ivc.The physician tried to pull the fractured leg out with no success as it would not move.The physician decided to leave the leg and was able to retrieve the remainder of the filter.The physician stated they were not concerned about migration as it would not move when attempted to remove.Patient outcome: did any unintended section of the device remain inside the patient¿s body? yes - one leg is embedded in the intima layer of the ivc.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description only, as no product was returned and no imaging could be obtained.Therefore, based on the limited information provided only, it would be inappropriate to speculate at what may or may not have caused a filter leg to fracture during the 10 years dwell time after placement due to trauma sustained from a motorcycle accident.However, it is noted that the filter was retrieved, but the fractured leg was left in the patient with no concern about migration, as it did not move during attempted retrieval.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.No evidence to suggest product 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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10222931
• MDR Text Key: 199723185
• Report Number: 3002808486-2020-00672
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other