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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND SILVERHAWK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Thrombosis (2100); Vascular Dissection (3160)
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 24 years¿ experience who was been using both the silverhawk and turbohawk directional atherectomy systems since 2017. The physician has used a total of 70 silverhawk peripheral plaque excision systems with 40 of these being used in the past 12 months. The physician reported the device related complications of arterial dissection, arterial spasm, and embolism or arterial thrombosis during use of the device. None of these events were reported previously to medtronic. The physician considered arterial dissection and arterial spasm events to be no at all concerning. The physician has commented that dissection is a complication provided by the technique of atherectomy and is easily treatable with stent implantation. Similarly, for spasm events the physician has reported it a complication provided by the technique of atherectomy and is easily treatable with administration of vasodilators. The embolism or arterial thrombosis event was reported to be somewhat concerning, and the physician has provided feedback that treatment is generally pharmacological and resolving.
 
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Brand NameSILVERHAWK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9450694
MDR Text Key179276801
Report Number9612164-2019-05106
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K061188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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