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

Model Number 10621

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Thrombosis/Thrombus (4440)

Event Date 02/18/2023

Event Type  Injury  

Event Description

It was reported that angina and thrombosis occurred.A 3.00 x 28 synergy was deployed to treat a 90% stenosed, mildly tortuous and moderately calcified target lesion located in the left circumflex.The patient was provided dual antiplatelet therapy (dapt), specifically asprin & clopidogrel.The patient experienced angina and angiogram revealed subacute stent thrombosis proximal to stent.A 3.00 x 16 synergy was deployed.The procedure was completed successfully and the patient was stable.

• 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: 16534707
• MDR Text Key: 311203260
• Report Number: 2124215-2023-11633
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0028732194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian