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

Model Number	H7493941820300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After informed consent was obtained, the patient was brought into the cardiac catheterization laboratory and prepped and draped in the usual sterile fashion.Coronary angiography was initially performed.Findings include a type iii lad.There is what appears to be a 60-70% lesion in the lad with dpr showing that this was significant.The team decided to proceed with intervention of the mid lad.When it was time for the synergy xd to be used, device was removed from the packaging and it was found to be defective with the end of shaft broken.The device was never inside the patient.This was replaced by another similar device and the procedure was completed without any further incident.No patient harm.Manufacturer response for coronary drug-eluting stent, synergy¿ xd (per site reporter.) device given to field representative.

• Brand Name: SYNERGY¿ XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16785070
• Report Number: 16785070
• Device Sequence Number: 5678940
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)240703(10)29764058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2023
• Report Date (Section F): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H7493941820300
• Device Catalogue Number: H7493941820300
• Device Lot Number: 29764058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White
• Date Report Sent to FDA: 04/18/2023