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	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified proximal circumflex artery.Following pre-dilatation with a semi-compliant and non-compliant balloons, a 3.00 x 28 synergy drug-eluting stent was advanced but failed to cross the lesion.The physician used a non-boston scientific stent which also failed to cross.Then, a 3.00 x 16 synergy xd drug-eluting stent was advanced but failed to cross the lesion as well.A 1.5 mm rotapro burr was used and further dilatation was performed with a 3.00 non-compliant balloon catheter.Another 3.00 x 28 was advanced but would not cross the lesion.The device was removed and it was noticed that a stent strut was lifted.The same non-boston scientific stent was used to complete the procedure.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: 12193669
• Report Number: 2134265-2021-09244
• Device Sequence Number: 19783859
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 07/19/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1