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

Model Number	H7493941820450
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A percutaneous coronary intervention was being performed.The 80% stenosed target lesion was located in the tortuous and calcified left anterior descending (lad) artery.A 4.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, resistance was met in the vessel right as the stent exited the guide catheter.The physician pushed and pulled the device and noticed that the hypotube came out without the distal part of the delivery system.The entire system was removed altogether to retrieve the broken part of the shaft.A 4.50 x 16mm synergy xd drug-eluting stent was advanced but met the same resistance and the shaft was bent but did not break.The physician tried one more balloon which did not cross so the procedure was stopped and the patient was sent to surgery.No patient complications related to the two stents were reported.

• Brand Name: SYNERGY XD
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13385591
• Report Number: 2134265-2022-00825
• Device Sequence Number: 11188014
• Product Code: NIQ
• UDI-Device Identifier: 08714729981206
• UDI-Public: 08714729981206
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: H7493941820450
• Device Lot Number: 0026892275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown