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

Device Problem Obstruction of Flow (2423)

Patient Problem Angina (1710)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Agent ide study.It was reported that stable angina occurred.On (b)(6) 2021, multiple synergy drug eluting stents implanted in left main (lm), left anterior descending artery (lad) and left circumflex artery (lcx).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 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 3.50 mm x 30 mm study device successfully with 30% residual stenosis and timi flow of 3.The non-target lesion was located at left main coronary artery (lmca) and was treated using 5.0 mm x 12 mm balloon successfully prior to target lesion treatment.The subject was discharged on aspirin and clopidogrel.

• 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: 18332466
• MDR Text Key: 330553649
• Report Number: 2124215-2023-71246
• 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

• Date FDA Received: 12/14/2023
• 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
• Date Manufacturer Received: 11/29/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: Black Or African American