MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Perforation (2001); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of turbohawk and silverhawk peripheral plaque excision systems.Survey results received for an interventional cardiologist with 12 years¿ experience who was been using the turbohawk peripheral plaque excision system since 2012.The physician has used a total of 60 turbohawk peripheral plaque excision systems with 12 of these being used in the past 12 months.The physician reported the device related complications of arterial perforation which leads to immediate pain in the patient and has so far been well sealed with prolonged pta, and embolism or arterial thrombosis which can occur when the filter wire slides or this does not seal well against the vessel wall, for example in case of wall irregularity.Often also mobilized plaques hang on the edge of the filter.During recovery of the filter, this can embolise.Often, plaque material is found after filter removal in the lock, so it must be well aspirated after recovery and then rinsed.The embolism that has taken place so far has been successfully aspirated.None of these events were reported previously to medtronic.The physician all of the events to be not at all concerning.The physician has not used the silverhawk peripheral plaque excision system.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway MN ; IE
• MDR Report Key: 9450845
• MDR Text Key: 171578863
• Report Number: 2183870-2019-00577
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention