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

Model Number 10623

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 11/08/2022

Event Type  Death  

Event Description

It was reported that the patient died due to cardiac arrest.The patient presented for double vessel percutaneous transluminal coronary angioplasty.An opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the mid left anterior descending artery (lad) to left main coronary artery (lmca).No ivus was performed on the left circumflex artery (lcx).A 2.50 x 28mm non-boston scientific stent was implanted in the mid lad and a 3.00 x 38mm synergy stent was deployed in the ostium to mid left circumflex artery (lcx).After deployment of the synergy, slow flow was observed.Treatment for slow flow was started and a 3.00 x 38mm synergy stent was immediately deployed in the lmca to lad, overlapping the mid lad stent.Slow flow remained and the patient developed bradycardia.The physician started pacing and the patient was given defibrillator shock, but the patient died of cardiac arrest due to slow flow and bradycardia.

• Brand Name: SYNERGY
• Type of Device: 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: 15834751
• MDR Text Key: 304021688
• Report Number: 2124215-2022-48084
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2024
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0029531590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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
• Treatment: STENT USED: ULTIMASTER 2.5 X 28.
• Patient Outcome(s): Other; Death
• Patient Sex: Male
• Patient Race: Asian