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

Model Number 10632

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

Patient Problems Arrhythmia (1721); Ischemia (1942); Ventricular Fibrillation (2130)

Event Date 01/25/2022

Event Type  Death  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that a patient death occurred.An angioplasty was performed on a left main coronary artery (lmca) to left anterior descending artery (lad) and right coronary artery (rca).A 2.75 x 48 synergy stent and another 2.75 x 48 synergy stent were deployed at the target lesions.Following deployment, the patient had no flow in the lad and left circumflex (lcx), incessant ventricular tachycardia and ventricular fibrillation vt/vf, which led to refractory arrhythmia.The procedure was unsuccessful, and the patient passed away.It was noted that the patient death occurred due to refractory arrhythmia.It was noted that physician did not consider the device or the procedure to have caused or contributed to the patient complications.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13528520
• MDR Text Key: 285600186
• Report Number: 2134265-2022-01591
• 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: 02/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0027535519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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): Death
• Patient Sex: Male
• Patient Race: Asian