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

Model Number 10620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 07/29/2021

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that atherosclerosis occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for catheterization.The index procedure was performed on the same day.The target lesion 1 was located in the left main coronary artery (lmca) extending up to the mid left anterior descending (lad) artery with 99% stenosis and was 45 mm long and a reference vessel diameter of 3.5 mm.Target lesion 1 was treated with placement of 3.5 mm x 24 mm and 3.00 mm x 28 mm synergy stent systems, and pre-dilatation was not performed.Following this, post-dilatation was performed with 99% residual stenosis.On the following day, the left ventricular ejection fraction (lvef) measured was 68%.Four days later, subject was discharged on ticagrelor and other antiplatelet medication.In (b)(6) 2021, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Coronary angiography without revascularization was performed to treat the event.Two days later, the subject was discharged and the event was considered recovering and resolving.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12556498
• MDR Text Key: 274112867
• Report Number: 2134265-2021-11767
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0023997297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• 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): Hospitalization; Other
• Patient Age: 63 YR