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

Model Number H7493941838350

Device Problem Fracture (1260)

Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It was reported that stent fracture and stent thrombosis occurred; the patient experienced myocardial infarction.The target lesion was located in middle right coronary artery.A 3.50 x 38mm synergy xd drug-eluting stent was implanted for treatment.The patient experienced arrhythmia, myocardial infarction, ischemia, and st elevation.It was noted that stent fracture occurred and caused stent thrombosis.Subsequently, the patient was brought back to catheterization laboratory after having st elevation and stenting was performed using a 3.50 x 38mm non-boston scientific stent.No further patient complications were reported and the patient fully recovered.

• Brand Name: SYNERGY XD
• 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: 15029303
• MDR Text Key: 295983876
• Report Number: 2134265-2022-07926
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: H7493941838350
• Device Lot Number: 0028974910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Female