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

Model Number 10623

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

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/13/2022

Event Type  Death  

Event Description

Synergy china registry.It was reported that the patient died.In (b)(6) 2020, the subject presented with unstable angina.The subject was referred for cardiac catheterization and the index procedure was performed the next day.The target lesion was located in the middle right coronary artery (rca) with 100% stenosis and was 38 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on clopidogrel and aspirin.In (b)(6) 2020, the staged procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.In (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.The subject also experienced cardiac failure.Medication was given to treat the event.Three days later, the subject died, and the primary cause of death is coronary atherosclerotic cardiopathy.It is unknown if an autopsy was performed.

Event Description

Synergy china registry it was reported that the patient died.In september 2020, the subject presented with unstable angina.The subject was referred for cardiac catheterization and the index procedure was performed the next day.The target lesion was located in the middle right coronary artery (rca) with 100% stenosis and was 38 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on clopidogrel and aspirin.In october 2020, the staged procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 38 mm synergy stent system.Following post dilatation, the residual stenosis was noted to be 0%.In november 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy and was hospitalized on the same day for further evaluation and treatment.The subject also experienced cardiac failure.Medication was given to treat the event.Three days later, the subject died, and the primary cause of death is coronary atherosclerotic cardiopathy.It is unknown if an autopsy was performed.It was further reported that the main cause of death is cardiac failure.

• 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: 16011007
• MDR Text Key: 305775004
• Report Number: 2124215-2022-51861
• 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: 12/22/2022

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: 11/24/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024862820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/11/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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): Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male