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 Problems Angina (1710); Restenosis (4576)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject 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 distal lad with 100 % stenosis and was 76 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm and 3.00 mm x 38 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, the subject was referred for coronary angiography and revascularization was recommended.On the same day, the 95% stenosis noted in middle lad which had previously placed study device was treated with percutaneous coronary intervention.Post intervention, the residual stenosis was 0%.After two days, the event was considered to be recovered/resolved and the subject was discharged on aspirin and clopidogrel.

Manufacturer Narrative

E1: (b)(6).

Manufacturer Narrative

B5: describe event or problem: updated with additional information.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).

Event Description

Synergy china registry: it was reported that unstable angina occurred.In (b)(6) 2020, the subject 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 distal lad with 100 % stenosis and was 76 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm and 3.00 mm x 38 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, the subject was referred for coronary angiography and revascularization was recommended.On the same day, the 95% stenosis noted in middle lad which had previously placed study device was treated with percutaneous coronary intervention.Post intervention, the residual stenosis was 0%.After two days, the event was considered to be recovered/resolved and the subject was discharged on aspirin and clopidogrel.It was further reported that in (b)(6) 2021, the 95% stenosis noted in proximal lad extended to distal lad which had previously placed study device was treated with percutaneous coronary intervention.

• 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: 18538057
• MDR Text Key: 333169376
• Report Number: 2124215-2023-74855
• 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,Followup
• Report Date: 02/21/2024

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: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0025011786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/21/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male