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

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.

• Brand Name: SILVERHAWK
• Type of Device: CATHETER, 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 Key: 9450694
• MDR Text Key: 179276801
• Report Number: 9612164-2019-05106
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention