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

Model Number 10619

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Synergy china registry it was reported that the patient experienced coronary atherosclerotic heart disease.In (b)(6) 2020, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the left main coronary artery (lmca) extending up to proximal left anterior descending (lad) artery with 90 % stenosis and was 18 mm long, with a reference vessel diameter of 3.8 mm.The target lesion was treated with pre-dilatation and placement of a 4.00 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Six days later, subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further treatment.On the next day, the subject was referred for coronary angiography which revealed 100% stenosis noted in lmca extending up to proximal lad which had previously placed study device was treated with percutaneous coronary intervention.Post intervention, the residual stenosis was 0%.Target vessel revascularization was performed, and medication was given to treat the event.One week later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18361168
• MDR Text Key: 330933448
• Report Number: 2124215-2023-71724
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

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: 01/05/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025076485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male