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

Model Number	H7493941828400
Medical Device Problem Codes	Fracture (1260); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.The patient presented with coronary artery disease.The 80% stenosed target lesion was located at the mildly tortuous and moderately calcified left main (lm) artery.A 4.00 x 28mm synergy xd drug eluting stent was advanced and implanted for treatment.Following post-dilatation of a kissing balloon catheter of the lm to left anterior descending/ circumflex and proximal optimisation technique (pot) of the lm, the mid portion of the synergy stent was fractured and deformed under flouroscopy.There was no intervention done to correct the fractured stent and the procedure was completed.No patient complications were reported and the patient status was stable.

• 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: 12642766
• Report Number: 2134265-2021-12676
• Device Sequence Number: 19656369
• Product Code: NIQ
• UDI-Device Identifier: 08714729981152
• UDI-Public: 08714729981152
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 02/16/2023
• Device Model Number: H7493941828400
• Device Lot Number: 0026877762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1