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

Model Number	H7493941812400
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and inadequate or insufficient apposition occurred.The 99% stenosed, target lesion was located in a severely tortuous and severely calcified obuse marginal branch segment/ left cirmuflex artery.The vessel was prepared with multiple balloons and a guidezilla guide extension catheter was needed to facilitate balloon and stent delivery.A 4.00x12mm synergy xd drug-eluting stent was deployed for treatment.However, during the initial inflation prior to reaching nominal pressure the balloon ruptured.It was noted that the balloon did not expand beyond the edges.The balloon was removed but the stent was severely underexpanded.After multiple attempts, 2.0 up to 4.0 balloons were used to fully inflate the stent and ensure adequate expansion.The patient was treated successfully with multiple stents back to the left main and the procedure was completed.No patient complications nor injuries reported.

• 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: 11558358
• Report Number: 2134265-2021-03054
• Device Sequence Number: 11813212
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• 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): 03/23/2021

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: 12/14/2022
• Device Model Number: H7493941812400
• Device Lot Number: 0026547433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/23/2021
• 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