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

Model Number	H7493941808300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 8mm synergy xd drug-eluting stent was selected for treatment.However, during preparation, the stent mounted on the balloon catheter became stuck in the carrier tube.The balloon and stent broke off the system as it was being removed from the carrier tube.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 8mm synergy xd drug-eluting stent was selected for treatment.However, during preparation, the stent mounted on the balloon catheter became stuck in the carrier tube.The balloon and stent broke off the system as it was being removed from the carrier tube.No patient complications were reported.It was further reported that the target lesion was located in left anterior descending artery.It was noted that the stent came off the balloon while taking out of the loop and there was no break at the hub.The procedure was completed with another of the same device and the patient condition was normal.

• 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: 15180583
• Report Number: 2134265-2022-08250
• Device Sequence Number: 20415424
• Product Code: NIQ
• UDI-Device Identifier: 08714729980940
• UDI-Public: 08714729980940
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/22/2022

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: 02/03/2024
• Device Model Number: H7493941808300
• Device Lot Number: 0028853425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/06/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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
• Patient Sex: Unknown