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

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

Patient Problems Obstruction/Occlusion (2422); Pseudoaneurysm (2605)

Event Date 06/21/2021

Event Type  Injury  

Event Description

This study trial review discusses the current data available for debris burden of different atherectomy devices and efficacy of infrainguinal epd.Several study trials were reported where spider fx embolic protection, silverhawk and turbohawk directional atherectomy were used in the procedure.The article reported the following adverse events reported in the trials reviewed: embolization, myocardial infarction, dissection, perforation and thrombus.Death was reported in the article but in patient with none medtronic device(s) used.No further injury reported.

Manufacturer Narrative

Event date: date of article publication.Review of embolic protection devices in percutaneous peripheral intervention vascular disease management (2021) 18(6):e95-e98.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12967147
• MDR Text Key: 281974555
• Report Number: 9612164-2021-04779
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 12/01/2021
• 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