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

Model Number	H7493941838250
Medical Device Problem Codes	Failure to Advance (2524); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that incorrect stent size was used.A 2.50 x 38mm synergy xd drug-eluting stent was advanced but failed to cross the lesion and it was noticed that the device has a wrong size.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that incorrect stent size was used.A 2.50 x 38mm synergy xd drug-eluting stent was advanced but failed to cross the lesion and it was noticed that the device has a wrong size.There were no patient complications nor injuries reported.It was further reported that the complaint has nothing to do with packaging.The physician has chosen the wrong size and just wanted a longer one.
Additional Manufacturer Narrative
(b5)describe event or problem and (h6) device codes corrected.

• 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: 12821059
• Report Number: 2134265-2021-14373
• Device Sequence Number: 5696888
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: 08714729980858
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 01/25/2023
• Device Model Number: H7493941838250
• Device Lot Number: 0026734557
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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 Sex: Unknown