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

Model Number	H7493941816270
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent could not cross the lesion and the stent strut was sticking up.The procedure was completed and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent could not cross the lesion and the stent strut was sticking up.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that the target lesion was located in the moderately calcified left anterior descending artery and the procedure was completed with a smaller-sized synergy drug-eluting stent.
Additional Manufacturer Narrative
B3 - date of event: updated event date to 05/24/2022.
Additional Manufacturer Narrative
E1.Initial reporter title: updated to dr.E1.Initial reporter first name: changed from don to none.E1.Initial reporter last name: changed from ladd to jama e1.Initial reporter phone: changed from (b)(6) b3 - date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent damage occurred.A 2.75 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent could not cross the lesion and the stent strut was sticking up.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that the target lesion was located in the moderately calcified left anterior descending artery and the procedure was completed with a smaller-sized synergy drug-eluting stent.

• 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: 14544786
• Report Number: 2134265-2022-06152
• Device Sequence Number: 6633667
• Product Code: NIQ
• UDI-Device Identifier: 08714729980889
• UDI-Public: 08714729980889
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 06/27/2022

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: 02/07/2024
• Device Model Number: H7493941816270
• Device Lot Number: 0028895438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 06/13/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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