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 Problem Cardiac Arrest (1762)

Event Date 01/30/2023

Event Type  Death  

Event Description

It was reported that the patient died.The patient presented with coronary artery disease (cad).The target lesion was located in left anterior descending artery.A 2.25 x 38 synergy drug-eluting stent was advanced for treatment.However, after deployment of the stent, patient went into cardiac arrest and died.

Event Description

It was reported that the patient died.The patient presented with coronary artery disease (cad).The target lesion was located in left anterior descending artery.A 2.25 x 38 synergy drug-eluting stent was advanced for treatment.However, after deployment of the stent, patient went into cardiac arrest and died.It was further reported that the 80% stenosed target lesion was moderately tortuous and moderately calcified.Furthermore, cardiac arrest was the official cause of death of the patient.

• 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: 16400818
• MDR Text Key: 309851861
• Report Number: 2124215-2023-04793
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BG
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0029357842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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
• Patient Outcome(s): Death