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); Ischemia (1942); Restenosis (4576)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter address 1: (b )(6).

Event Description

Synergy china registry it was reported that the patient experienced stable angina pectoris.In january 2023, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the first right posterolateral segment (rpl) with 100% stenosis and was 44 mm long, with a reference vessel diameter of 3.50 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm and 3.50 mm x 16 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.Eight days later in (b)(6) 2023, the staged procedure was performed.The target lesion was located in the middle left anterior descending artery (lad) with 80% stenosis and was 36 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 16 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Six days post staged procedure, the subject was discharged on aspirin and clopidogrel.In (b)(6)v 2024, the subject was diagnosed with stable angina pectoris and was hospitalized on the same day for further treatment.Percutaneous coronary intervention (pci) was performed; however, it was non-target vessel revascularization (non-tvr).Medication was adjusted to treat the stable angina.Five days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the outcome of the event was considered to be recovering/resolving.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).

Event Description

Synergy china registry: it was reported that the patient experienced stable angina pectoris.In (b)(6) 2023, the subject presented with stable angina and was referred for cardiac catheterization.The target lesion 1 was located in the first right posterolateral segment (rpl) with 100% stenosis and was 44 mm long, with a reference vessel diameter of 3.50 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 28 mm and 3.50 mm x 16 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.Eight days later in (b)(6) 2023, the staged procedure was performed.The target lesion was located in the middle left anterior descending artery (lad) with 80% stenosis and was 36 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of 2.75 mm x 16 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Six days post staged procedure, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2024, the subject was diagnosed with stable angina pectoris and was hospitalized on the same day for further treatment.Percutaneous coronary intervention (pci) was performed; however, it was non-target vessel revascularization (non-tvr).Medication was adjusted to treat the stable angina.Five days later, the subject was discharged on aspirin and clopidogrel.At the time of reporting, the outcome of the event was considered to be recovering/resolving.It was further reported that in january 2024, the patient was hospitalized with positive stress test or other objective evidence of cardiac ischemia.On the same day, the subject was referred for coronary angiography which revealed 80% stenosis noted in middle lad which had previously placed study device was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, residual stenosis was 0%.Five days after, the subject was discharged.

• 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: 18918562
• MDR Text Key: 337843820
• Report Number: 2124215-2024-13049
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0029622289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: 56 YR
• Patient Sex: Male