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

Lot Number 0032340396

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

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969)

Event Date 01/11/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced myocardial infarction and chest pain requiring additional intervention.Following pre-dilatation, intravascular ultrasound (ivus) was performed.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.Following post-dilatation, ivus was again performed to complete the procedure.There were no adverse events, and the patient was transferred to the patient care unit.The patient complained of chest pain, and electrocardiogram (ekg) changes were shown approximately 60 minutes post-implantation.It was noted that the patient experienced myocardial infarction and ischemia.The patient was brought back to the cardiac catheterization lab, ivus was completed and balloon angioplasty was performed to expand the stent.The patient returned to the patient care unit and tolerated the procedure well.There were no patient complications reported and the patient was expected to fully recover.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18672724
• MDR Text Key: 334947873
• Report Number: 2124215-2024-05321
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0032340396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 83 KG