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

Model Number	H7493941820350
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure while attempting to pass into overlapping stents, it was noted that the stent distal end was damaged.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure while attempting to pass into overlapping stents, it was noted that the stent distal end was damaged.The procedure was completed with another of same device.There were no patient complications nor injuries reported.It was further reported that the 90% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.It was also noted that the procedure was not completed and the patient was stable post procedure.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11785690
• Report Number: 2134265-2021-05865
• Device Sequence Number: 3659819
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 10/20/2022
• Device Model Number: H7493941820350
• Device Lot Number: 0026264197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1