MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10607
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure, removal difficulties, and stent foreshortening occurred.The 90% stenosed target lesion was located in the distal and proximal right coronary artery.A 3.5 x 38 mm synergy ii drug-eluting stent was deployed for treatment.The stent balloon was inflated at 18 atmospheres for 20 seconds.However, it was observed that the balloon became stuck and was not able to deflate fully.Subsequently, the balloon was deflated by the indeflator.During the removal, the deflated balloon was pulled on the stent and it caused foreshortening.An additional 3.5x12mm synergy stent was implanted.The procedure was completed without any other issues and the patient was stable throughout the case.No patient complications were reported.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11497064
• Report Number: 2134265-2021-02772
• Device Sequence Number: 20176841
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 03/16/2021

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: 11/16/2022
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0026425861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: JR4; GUIDEWIRE: SION BLUE
• Outcome Attributed to Adverse Event: Required Intervention