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

Model Number	10610
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 95% stenosed target lesion was located in the moderately tortuous and calcified ostial right coronary artery.A 4.00 x 16 synergy drug-eluting stent was deployed for treatment.However, following deployment, the balloon would not move over the wire.The balloon was reinflated and deflated and tried again to remove.The device was still locked onto the wire, and so everything was removed from the patient.Another catheter for final images was placed, and the stent and artery looked good with no patient complications and the procedure was completed.

• 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: 11272955
• Report Number: 2134265-2021-00755
• Device Sequence Number: 17200771
• Product Code: NIQ
• UDI-Device Identifier: 08714729840619
• UDI-Public: 08714729840619
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 02/03/2021

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: 07/08/2022
• Device Model Number: 10610
• Device Catalogue Number: 10610
• Device Lot Number: 0025723864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR