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

Model Number 10621

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Synergy china registry.It was reported that subject presented with coronary atherosclerotic cardiopathy.In (b)(6) 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.The target lesion#1 was located in the proximal left anterior descending artery (lad) with 75% stenosis and was 28 mm long, with a reference vessel diameter of 2.5 mm.The target lesion#1 was treated with pre-dilatation and placement of a 2.50 mm x 28 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The target lesion#2 was located in the middle lad extending up to distal lad with 85 % stenosis and was 38 mm long with a reference vessel diameter of 3.0 mm.The target lesion#2 was treated with pre-dilatation and placement of a 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Six days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject presented with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further treatment.Medication was given to treat the event.Three days later, the subject was discharged on aspirin and ticagrelor.At the time of reporting the event was considered to be recovering/ resolving.

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: 18307823
• MDR Text Key: 330220932
• Report Number: 2124215-2023-68536
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0023749656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male