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

Model Number	10603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 28 synergy ii drug eluting coronary stent system was advanced, however, during the stent insertion to the guide catheter the stent shaft broke.No patient complications or issues that he is aware of at this time.
Additional Manufacturer Narrative
E1 initial reporter title updated.E1 initial reporter first name corrected.E1 initial reporter last name corrected.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 28 synergy ii drug eluting coronary stent system was advanced, however, during the stent insertion to the guide catheter the stent shaft broke.No patient complications or issues that he is aware of at this time.It was further reported that the lesion appeared to be calcified and somewhat tortuous.The device was completely removed by just pulling back on the guidewire and the procedure was completed with another of the same device.

• 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: 12203889
• Report Number: 2134265-2021-09346
• Device Sequence Number: 17200414
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/13/2021

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: 12/02/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0026498736
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1