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 09/02/2023

Event Type  Injury  

Event Description

Synergy china registry it was reported that unstable angina pectoris occurred requiring medication.In august 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) extending up to middle lcx with 90% stenosis and was 3.0 mm long with a reference vessel diameter of 12 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal left anterior descending (lad) artery extending up to middle lad with 80% stenosis and was 3.0 mm long with a reference vessel diameter of 16 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 mm x 20 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In september 2023, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further treatment.Non-target vessel revascularization was performed, and medication was given to treat the event.Five days later, the outcome of the event was considered to be recovered and resolved.The subject was discharged on aspirin and ticagrelor.

Event Description

Same case as pr id# (b)(4).Synergy china registry it was reported that unstable angina pectoris occurred requiring medication.In (b)(6) 2022, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) extending up to middle lcx with 90% stenosis and was 3.0 mm long with a reference vessel diameter of 12 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal left anterior descending (lad) artery extending up to middle lad with 80% stenosis and was 3.0 mm long with a reference vessel diameter of 16 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 mm x 20 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further treatment.Non-target vessel revascularization was performed, and medication was given to treat the event.Five days later, the outcome of the event was considered to be recovered and resolved.The subject was discharged on aspirin and ticagrelor.It was further reported that in (b)(6) 2023, the subject presented with symptoms of angina and was hospitalized on the same day for further treatment.Coronary angiography revealed 50% stenosis in the proximal lad extending up to the middle lad which had previously placed study device and was treated with percutaneous coronary intervention.Post intervention, residual stenosis was 0%.At the time of the event, the subject was 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: 18531347
• MDR Text Key: 333088805
• Report Number: 2124215-2023-76062
• 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: 04/17/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0028419669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male