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

Model Number 10622

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Synergy china registry: it was reported that atherosclerotic heart disease occurred.On (b)(6) 2020, the patient presented with myocardial infarction and was referred for cardiac catheterization.On the same day, index procedure was performed.The target lesion #1 was located in the mid left anterior descending (lad) artery with 100% stenosis, was 32 mm long and a reference vessel diameter of 3.0 mm.The target lesion #1 was treated with pre-dilation and placement of a 3.00 mm x 32 mm synergy stent system.Following this post dilation was performed with 0% residual stenosis.Ten days later, the patient was discharged on other medication and ticagrelor.On (b)(6) 2022, the patient was hospitalized for further evaluation and treatment of arteriosclerotic heart disease.The event was treated medically.At the time of reporting the outcome of the event was considered to be recovering/resolving.Two days later, the subject was discharged on other medication and ticagrelor.

• 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: 16017862
• MDR Text Key: 305841039
• Report Number: 2124215-2022-51550
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024914510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• 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): Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male