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 Problems Angina (1710); Thrombosis/Thrombus (4440)

Event Date 01/28/2023

Event Type  Injury  

Event Description

Synergy china registry it was reported that patient experienced unstable angina pectoris.In june 2020, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending (lad) artery with 99% stenosis and was 13 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with a direct placement of 3.00 mm x 16 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.Pre-dilatation was not performed.On the following day, the subject was discharged on aspirin and clopidogrel.In january 2023, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) to mid lad was performed to treat the event.In february 2023, four days after the january 2023 hospital admission, the event was considered to be recovering/resolving and the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry.It was reported that patient experienced unstable angina pectoris.In (b)(6) 2020, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion was located in the proximal left anterior descending (lad) artery with 99% stenosis and was 13 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with a direct placement of 3.00 mm x 16 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.Pre-dilatation was not performed.On the following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment.Percutaneous transluminal coronary angioplasty (ptca) to mid lad was performed to treat the event.In (b)(6)2023, four days after the (b)(6) 2023 hospital admission, the event was considered to be recovering/resolving and the subject was discharged on aspirin and clopidogrel.It was further reported that the angiography revealed 30% stenosis in proximal lad extended up to middle lad and the patient was diagnosed with stent thrombosis on early (b)(6) 2023.The patient was referred for a coronary angiography on the end of (b)(6) 2023.Revascularization was recommended.The 100% stenosis noted in the proximal lad that extended up to the distal lad which had a previously placed study device was treated with percutaneous coronary intervention.Post intervention, the residual stenosis was noted to be 0%.The next day, the event was considered to be recovering/ resolving and the subject was discharged on aspirin and clopidogrel.

• 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: 17382879
• MDR Text Key: 319747077
• Report Number: 2124215-2023-37370
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0024012712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male