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

Model Number 10619

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/09/2021

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that acute exacerbation of chronic heart failure occurred.In (b)(6) 2020, the subject presented with unstable angina and referred for cardiac catherization.It was noted that the subject's left ventricular ejection fraction (lvef) measurement was 31%.Index procedure was performed on the same day.The target lesion 1 was located in proximal left anterior descending (lad) artery with 90% stenosis and was 16mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the proximal lad extending up to distal lad with 50% stenosis and was 34 mm long with a reference vessel diameter of 3.5 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.50 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with acute exacerbation of chronic heart failure and hospitalized for further evaluation and treatment.Medication was given to treat the event and at the time of reporting the outcome of the event was considered to be recovering and resolving.Five days later, the subject was discharged on aspirin and ticagrelor.

Event Description

Synergy china registry: it was reported that acute exacerbation of chronic heart failure occurred.In (b)(6) 2020, the subject presented with unstable angina and referred for cardiac catherization.It was noted that the subject's left ventricular ejection fraction (lvef) measurement was 31%.Index procedure was performed on the same day.The target lesion 1 was located in proximal left anterior descending (lad) artery with 90% stenosis and was 16mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.00 x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The target lesion 2 was located in the proximal lad extending up to distal lad with 50% stenosis and was 34 mm long with a reference vessel diameter of 3.5 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.50 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was (b)(4).Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with acute exacerbation of chronic heart failure and hospitalized for further evaluation and treatment.Medication was given to treat the event and at the time of reporting the outcome of the event was considered to be recovering and resolving.Five days later, the subject was discharged on aspirin and ticagrelor.It was further reported that target lesion 1 was located in proximal left circumflex artery (lcx) and not in the lad as previously reported.Furthermore, the physician considers the study device was unlikely related to the event.

• 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: 12716817
• MDR Text Key: 279017781
• Report Number: 2134265-2021-13304
• 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,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025027309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male