MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10620

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/08/2023

Event Type  Injury  

Event Description

Synergy china registry it was reported that stent thrombosis occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the middle left anterior descending artery (lad) extended to distal lad with 95% stenosis and was 20 mm long and a reference vessel diameter of 2.3 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 24 mm synergy stent system.Following post dilation, the residual stenosis was noted to be 0%.Three days later, subject was discharged on aspirin and ticagrelor.In (b)(6) 2023, the subject was diagnosed with coronary stent thrombosis in the mid lad and was hospitalized for further evaluation and treatment.Medication was given to treat the event.Four days later, the event was considered recovered/resolved and the subject was discharged four days after.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16542581
• MDR Text Key: 311287530
• Report Number: 2124215-2023-10307
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0025337065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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: 58 YR
• Patient Sex: Male