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 Problems Angina (1710); Restenosis (4576)

Event Date 08/14/2023

Event Type  Injury  

Event Description

Synergy china registry.It was reported that unstable angina and restenosis occurred.In (b)(6) 2022, the subject presented with myocardial infarction was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending (lad) artery with 100% stenosis and was 30 mm long, with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Seven days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with unstable angina pectoris and was hospitalized for further treatment.Eight days later, the subject was referred for coronary angiography which revealed 85% stenosis noted in proximal lad extending up to middle lad which had previously placed study device was treated with percutaneous coronary intervention.Post intervention, residual stenosis was 0%.Additionally, medication was given to treat the event.Two days later, the event was considered to be recovered/resolved and the subject was discharged on aspirin and ticagrelor.

• 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: 18779375
• MDR Text Key: 336233997
• Report Number: 2124215-2024-08826
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2023
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0027907974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male