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

Model Number H7493941820300

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2023

Event Type  malfunction  

Event 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16785070
• MDR Text Key: 313750210
• Report Number: 16785070
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)240703(10)29764058
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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
• Date Report Sent to FDA: 04/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White