MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

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

Patient Problem Vasoconstriction (2126)

Event Date 04/22/2019

Event Type  Injury  

Event Description

It was reported that vasospasm occurred.A.014 guidewire was selected for used together with the filterwire for use during a stenting procedure.The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance.The stent was removed due to the guidewire advancement restriction.Angiography was performed and the patient experienced vasospasm; subsequently the filterwire was removed then the angiography was performed again.The.014 guidewire was put in place, and the 7x40 stent was opened, however; the.014 guidewire still could not cross the 7x30 stent.Another device was used to complete the procedure.No further patient complications were reported.

Event Description

It was reported that vasospasm occurred.A.014 guidewire was selected for used together with the filterwire for use during a stenting procedure.The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance.The stent was removed due to the guidewire advancement restriction.Angiography was performed and the patient experienced vasospasm; subsequently the filterwire was removed then the angiography was performed again.The.014 guidewire was put in place, and the 7x40 stent was opened, however; the.014 guidewire still could not cross the 7x30 stent.Another device was used to complete the procedure.No further patient complications were reported.It was further reported that the carotid wallstent was inserted onto the filterwire and the guide wire; and during the time of vasospasm, the devices were inside the patient's body.It was further reported that the guidewire used was a non-bsc device.

Event Description

It was reported that vasospasm occurred.A.014 guidewire was selected for used together with the filterwire for use during a stenting procedure.The guidewire reach the junction of the carotid artery stent but after several attempts the guidewire could not advance.The stent was removed due to the guidewire advancement restriction.Angiography was performed and the patient experienced vasospasm; subsequently the filterwire was removed then the angiography was performed again.The.014 guidewire was put in place, and the 7x40 stent was opened, however; the.014 guidewire still could not cross the 7x30 stent.Another device was used to complete the procedure.No further patient complications were reported.It was further reported that the carotid wallstent was inserted onto the filterwire and the guide wire; and during the time of vasospasm, the devices were inside the patient's body.

• Brand Name: FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8619799
• MDR Text Key: 145377449
• Report Number: 2134265-2019-05421
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• PMA/PMN Number: K061332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 61