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 Problems Chest Pain (1776); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 03/18/2022

Event Type  Injury  

Event Description

Synergy (b)(6) registry it was reported that arteriosclerotic heart disease occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the proximal right coronary artery (rca) with 85% stenosis and was 32 mm long, with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.50 mm x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days post procedure, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with arteriosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Five days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.

Event Description

Synergy china registry.It was reported that arteriosclerotic heart disease occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the proximal right coronary artery (rca) with 85% stenosis and was 32 mm long, with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.50 mm x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Three days post procedure, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with arteriosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Five days later, the event was considered to be recovered/resolved and on the same day the subject was discharged on aspirin and ticagrelor.It was further reported that the patient was hospitalized with chest tightness.There was no re-stenosis of other blood vessels in the patient, and there was no more evidence to prove that the patient physical discomfort was unrelated to the device.Therefore, the correlation between the patient physical discomfort and the device could not be ruled out.

Manufacturer Narrative

B5-describe event or problem has been updated.H6.Patient code-added.

• 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: 14283763
• MDR Text Key: 290761947
• Report Number: 2134265-2022-04778
• 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: 11/04/2022

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: 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
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 11/04/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male