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

Model Number	H7493941812250
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon while it was being delivered to the lesion, while in the guide catheter.The stent was removed intact from the guide catheter with no patient complications were reported.
Additional Manufacturer Narrative
Updated b5: describe event or problem.Updated e1.Initial reporter title, initial reporter first name, initial reporter last name, and initial reporter phone.
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon while it was being delivered to the lesion, while in the guide catheter.The stent was removed intact from the guide catheter with no patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the non tortuous and mildly calcified 2nd diagonal branch.The guide catheter was flushed on the table and the entire undeployed stent came out of the guide catheter.

• 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: 13664871
• Report Number: 2134265-2022-02260
• Device Sequence Number: 4756262
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: 08714729980797
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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
• Report Date (Section B): 04/01/2022

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: 09/13/2023
• Device Model Number: H7493941812250
• Device Lot Number: 0028047249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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