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

Model Number 10622

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

Patient Problem Arteriosclerosis/ Atherosclerosis (4437)

Event Date 10/25/2022

Event Type  Injury  

Event Description

Synergy china registry it was reported that coronary atherosclerotic cardiopathy occurred.In (b)(6) 2020, the subject was presented with myocardial infarction and was referred for cardiac catheterization.On the same day the index procedure was performed.The target lesion #1 was located in proximal left anterior descending (lad) artery with 100% stenosis and was 32 mm long with a reference vessel diameter of 3.5 mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50 mm x 32 mm synergy china registry stent system.Following post dilation, the residual stenosis was 0%.Six days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy, and no action was taken to treat the event.Two days later, the event was recovered, and the subject was discharged on aspirin and ticagrelor.

Manufacturer Narrative

B2: outcomes attrib to adv event: updated.H6.Impact codes (1): updated from hospitalization or prolonged hospitalization to medication required.

Event Description

Synergy china registry: it was reported that coronary atherosclerotic cardiopathy occurred.In april 2020, the subject was presented with myocardial infarction and was referred for cardiac catheterization.On the same day the index procedure was performed.The target lesion #1 was located in proximal left anterior descending (lad) artery with 100% stenosis and was 32 mm long with a reference vessel diameter of 3.5 mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50 mm x 32 mm synergy china registry stent system.Following post dilation, the residual stenosis was 0%.Six days later, the subject was discharged on aspirin and ticagrelor.In october 2022, the subject was diagnosed with coronary atherosclerotic cardiopathy, and no action was taken to treat the event.Two days later, the event was recovered, and the subject was discharged on aspirin and ticagrelor.It was further reported that medication was given to treat 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16018505
• MDR Text Key: 305869918
• Report Number: 2124215-2022-51223
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024062929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female