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

Model Number	H7493941848270
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch that stent dislodgement inside the patient occurred.As a 2.75 x 48mm synergy xd drug-eluting stent was being advanced for treatment when a portion of the stent came off of balloon-stylette removed from balloon easily.Unfortunately, device was not saved.No known harm to patient.
Event or Problem Description
It was reported via facility medwatch that stent dislodgement inside the patient occurred.As a 2.75 x 48mm synergy xd drug-eluting stent was being advanced for treatment a portion of the stent came off of balloon-stylette removed from balloon easily.Unfortunately, device was not saved.No known harm to patient.It was further reported that the event date was (b)(6) 2021.
Event or Problem Description
It was reported via facility medwatch that stent dislodgement inside the patient occurred.As a 2.75 x 48mm synergy xd drug-eluting stent was being advanced for treatment a portion of the stent came off of balloon-stylette removed from balloon easily.Unfortunately, device was not saved.No known harm to patient.It was further reported that the event date was (b)(6) 2021.It was further reported that positive stress test lead to the procedure: cardiac cath with percutaneus intervention, stents and balloon angioplasty.During the procedure, a portion of the stent came off of balloon- stylette removed from balloon easily, no known harm to patient.Unfortunately device was not saved.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13252638
• Report Number: 2134265-2022-00218
• Device Sequence Number: 4753386
• Product Code: NIQ
• UDI-Device Identifier: 08714729985211
• UDI-Public: 08714729985211
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

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: 07/07/2023
• Device Model Number: H7493941848270
• Device Lot Number: 0027681197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 01/12/2022; 03/18/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/01/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 60 KG