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

Model Number 10618

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

Patient Problem Angina (1710)

Event Date 07/26/2023

Event Type  Injury  

Event Description

Synergy china registry.It was reported that the patient experienced unstable angina pectoris.In (b)(3) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the middle left anterior descending (lad) artery with 90% stenosis and was 13mm long, with a reference vessel diameter of 3.00mm.The target lesion was treated with pre-dilatation and following by placement of a 3.00mm x 16mm synergy stent system.Residual stenosis was 0%.Post dilatation was not performed.Seven days later, the subject was discharged on aspirin and clopidogrel.In (b)(3) 2023, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further treatment.Medication was given to treat the event.Seven days later, the outcome of the event was recovered and resolved.The subject was discharged on aspirin and clopidogrel.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) university.E1 - initial reporter phone: (b)(3).

• 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: 18374817
• MDR Text Key: 331122694
• Report Number: 2124215-2023-72762
• 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: 12/21/2023

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: 12/18/2021
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0024996019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: 67 YR
• Patient Sex: Male