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

Model Number	H7493941824350
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A 3.5mm by 24 synergy xd drug-eluting coronary stent was deployed to the mid right coronary artery.Stent fully deployed but the balloon did not fully deflate.The balloon could not be pulled back into the guide catheter.The balloon and guide catheter successfully removed from the patient's body.No harm caused to the patient.Manufacturer response for coronary drug-eluting stent, synergy¿ xd (per site reporter): the local boston scientific representative was notified of this event.They are reporting this event on their end and has requested the device as soon as we can release it to them.

• Brand Name: SYNERGY¿ XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17508816
• Report Number: 17508816
• Device Sequence Number: 6363873
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: (01)08714729981060(17)250206(10)31091705
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/21/2023
• Report Date (Section F): 07/21/2023

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 Model Number: H7493941824350
• Device Lot Number: 31091705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White
• Date Report Sent to FDA: 07/21/2023