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

Model Number	10605
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent would not advance through the lesion.The device was removed and a guidezilla guide extension catheter was placed.When the device was re-inserted, it was found that the stent was unraveled from the balloon.No patient complications nor injuries reported.
Additional Manufacturer Narrative
E4 init rptr also sent rep to fda: corrected.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent would not advance through the lesion.The device was removed and a guidezilla guide extension catheter was placed.When the device was re-inserted, it was found that the stent was unraveled from the balloon.No patient complications nor injuries reported.It was further reported that the event was reported via medwatch 300840000-2021-8047.The patient presented with a new onset of chest pain.During the procedure, the synergy stent impacted a calcium buildup and was removed.When attempting to reinsert the device it was noted that the device unraveled distally on the balloon with a fragment of the stent protruding from the device itself.A new device was used with no known harm to the patient.

• 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: 11688998
• Report Number: 2134265-2021-05015
• Device Sequence Number: 3097405
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• 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,Followup
• Report Date (Section B): 05/10/2021

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: 11/16/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0026404846
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 110