MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Activation Failure (3270)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Agent ide study.It was reported that in-stent restenosis and stent under-expansion occurred.On (b)(6) 2021, the proximal circumflex artery (cx) was treated with balloon angioplasty and synergy drug eluting stent (des).On (b)(6) 2022, the subject presented with stable angina and was referred for the agent ide study.The 90% stenosed target lesion was located at proximal cx and was 10 mm long with a reference vessel diameter of 3.5 mm.The target lesion was predilated using a 4.0 mm x 20 mm nc balloon and laser atherectomy with 30% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with a 3.50 mm x 30 mm study device successfully with 30% residual stenosis and timi flow of 3.The subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject presented to hospital due to the ongoing chest pain for over last 2 months consistent with progressive stable angina despite optimal medical therapy.The subject was on aspirin and clopidogrel.The subject was diagnosed with stable angina due to coronary artery disease.The 95% stenosis noted at distal left circumflex artery (lcx) was predilated with 3.5 nc balloons.Post this, intravascular ultrasound (ivus) revealed under-expansion of the previously placed synergy stent in the proximal lcx which was successfully dilated with 3.5 non-boston scientific balloon.Later, the distal lcx was treated with a 3.0 mm x 16 mm synergy drug eluting stent followed by post dilation with 3.5 mm nc balloons.Post revascularization, the residual stenosis was noted as 0% with timi flow 3.The event was considered to be recovered/resolved.The subject was discharged on dapt.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 18332959
• MDR Text Key: 330545938
• Report Number: 2124215-2023-71245
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Male
• Patient Race: Black Or African American