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

Model Number	H7493941808220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary arterial disease and underwent percutaneous coronary intervention.The target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.A 2.25 x 8mm synergy xd drug-eluting stent was advanced through a guide catheter and guidezilla guide extension catheter.The physician decided to remove the guidezilla to make the stent delivery easier.However, it was noted that when the stent was pulled out of the body, the shaft broke in half.The broken shaft was pulled out intact.A 2.50 x 8mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.Upon removal, it was noted that the stent was frayed.Another 2.50 x 8mm synergy xd drug-eluting stent was used to complete the procedure.No patient complications 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15788449
• Report Number: 2124215-2022-46541
• Device Sequence Number: 5747461
• Product Code: NIQ
• UDI-Device Identifier: 08714729980704
• UDI-Public: 08714729980704
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 04/29/2023
• Device Model Number: H7493941808220
• Device Lot Number: 0027278962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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