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

Model Number	H7493941848270
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fracture and cardiac arrest occurred requiring resuscitation and additional intervention.The patient underwent percutaneous coronary intervention (pci) of the non-tortuous mid left anterior descending artery.A 2.75 x 48mm synergy xd drug-eluting stent was implanted.However, after removing the post-dilatation balloon catheter, a stent fracture was observed.A rotablator was subsequently used to gain access as the devices could not pass, and another stent was placed.During the procedure, the patient went into cardiac arrest.The patient was resuscitated, and the patient condition was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16714740
• Report Number: 2124215-2023-16354
• Device Sequence Number: 16547790
• Product Code: NIQ
• UDI-Device Identifier: 08714729985211
• UDI-Public: 08714729985211
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: H7493941848270
• Device Lot Number: 0029317760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown