MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941812270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)
Date of Event	06/22/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient came in for a planned multi-vessel percutaneous coronary intervention of the left anterior descending artery (lad) and circumflex artery (cx).The physician initially wired the lad and diagonal branch.Following use of a non-boston scientific (bsc) balloon, a 3.00 x 24mm synergy xd drug-eluting stent (des) was deployed in the mid lad.Post-dilatation was performed with a 3.25 nc quantum apex balloon catheter.The physician then proceeded to wire the cx and intravascular ultrasound (ivus) was performed with the opticross 6 hd.After imaging, the patient experienced st elevation and when the physician checked the lad, it showed timi 0 flow.The physician believed the ivus may have broken off a piece of plaque which showered down the lad.The physician proceeded to stent the cx with a 2.75 x 20mm synergy xd des and ballooned the lad stent again.A 2.75 x 12mm synergy xd des was then placed distal to the 3.0 in the lad.The patient was coded and a non boston scientific ventricular assist device was placed.During the procedure the patient also experienced arrhythmia, thrombosis, ventricular fibrillation, and ventricular tachycardia.The patient was transferred to another facility for extracorporeal membrane oxygenation.The patient subsequently died.
Event or Problem Description
It was reported that the patient died.The patient came in for a planned multi-vessel percutaneous coronary intervention of the left anterior descending artery (lad) and circumflex artery (cx).The physician initially wired the lad and diagonal branch.Following use of a non-boston scientific (bsc) balloon, a 3.00 x 24mm synergy xd drug-eluting stent (des) was deployed in the mid lad.Post-dilatation was performed with a 3.25 nc quantum apex balloon catheter.The physician then proceeded to wire the cx and intravascular ultrasound (ivus) was performed with the opticross 6 hd.After imaging, the patient experienced st elevation and when the physician checked the lad, it showed timi 0 flow.The physician believed the ivus may have broken off a piece of plaque which showered down the lad.The physician proceeded to stent the cx with a 2.75 x 20mm synergy xd des and ballooned the lad stent again.A 2.75 x 12mm synergy xd des was then placed distal to the 3.0 in the lad.The patient was coded and a non boston scientific ventricular assist device was placed.During the procedure the patient also experienced arrhythmia, thrombosis, ventricular fibrillation, and ventricular tachycardia.The patient was transferred to another facility for extracorporeal membrane oxygenation.The patient subsequently died.
Additional Manufacturer Narrative
H6 patient codes: corrected.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14937813
• Report Number: 2134265-2022-07495
• Device Sequence Number: 6147925
• Product Code: NIQ
• UDI-Device Identifier: 08714729980872
• UDI-Public: 08714729980872
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: H7493941812270
• Device Lot Number: 0028065976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Death
• Patient Sex: Female