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

Model Number	39260-2427
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Stent balloon rupture during balloon angioplasty.Fda safety report id # (b)(4).

• Brand Name: SYNERGY XD MONORAIL CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15789372
• Report Number: MW5113226
• Device Sequence Number: 16903712
• Product Code: NIQ
• UDI-Device Identifier: 08714729980902
• UDI-Public: 08714729980902
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2024
• Device Model Number: 39260-2427
• Device Catalogue Number: H7493941824270
• Device Lot Number: 29963783
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White