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

Model Number	H7493941832400
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation issues occurred.A 12mm x 2.50mm nc quantum apex and a 4.00 x 32mm synergy xd were selected for use.During the procedure, after the stent was successfully delivered and expanded, it was noted that the balloon got stuck in the guide.Another inflation device was used in an attempt to fully deflate the balloon, but it remained stuck in the guide, so a wire was used to pop and further deflate the balloon.Next the nc balloon got stuck in the guide after deflation and the nc balloon was also popped to further deflate.The balloon was removed and the procedure was completed successfully.There were no patient complications.
Event or Problem Description
It was reported that deflation issues occurred.A 12mm x 2.50mm nc quantum apex and a 4.00 x 32mm synergy xd were selected for use.During the procedure, after the stent was successfully delivered and expanded, it was noted that the balloon got stuck in the guide.Another inflation device was used in an attempt to fully deflate the balloon, but it remained stuck in the guide, so a wire was used to pop and further deflate the balloon.Next the nc balloon got stuck in the guide after deflation and the nc balloon was also popped to further deflate.The balloon was removed and the procedure was completed successfully.There were no patient complications.
Additional Manufacturer Narrative
H6 device codes: corrected.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 16809412
• Report Number: 2124215-2023-19072
• Device Sequence Number: 2996991
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 08/07/2024
• Device Model Number: H7493941832400
• Device Lot Number: 0029995432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: Required Intervention
• Patient Sex: Unknown