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 Heart Failure/Congestive Heart Failure (4446)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter city: yuexiu district guangdong province.

Event Description

Synergy china registry it was reported that heart failure occurred.In (b)(6)2019, the patient presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending artery (lad) extending up to middle lad with 85% stenosis and was 35 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and followed by placement of 3.00 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with cardiac function grade ii.Medication was given to treat the event.At the time of reporting, the event was considered not recovered and not resolved.

• 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: 18052321
• MDR Text Key: 327124718
• Report Number: 2124215-2023-60248
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023560063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male