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

Model Number	H7493941832300
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent narrowing occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the heavily calcified left anterior descending artery.Bed preparation was performed with an opticross imaging catheter, a 3.0 non-boston scientific intravascular lithotripsy catheter, and a 3.0 noncompliant (nc) balloon catheter which were each advanced into the lesion without any issues.A 3.00 x 32mm synergy xd drug eluting-stent was advanced for treatment.However, after deployment, a narrowing in the mid part of the stent was noted.The stent was post-dilated with a 3.0 nc emerge balloon, however, the lesion was still present.The procedure was completed successfully.No patient complications were reported and the patient status was stable throughout the procedure.
Additional Manufacturer Narrative
Date of event: used the first date of the month of aware date as no information was provided.Implant date: used the first date of the month of aware date as no information was provided.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16039854
• Report Number: 2124215-2022-52243
• Device Sequence Number: 6437097
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: 06/06/2024
• Device Model Number: H7493941832300
• Device Lot Number: 0029598729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: 3.0 NONCOMPLIANT BALLOON; IMAGING CATHETER: OPTICROSS; IVL CATHETER: 3.0 SHOCKWAVE
• Patient Sex: Unknown