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

Model Number	10601
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was exposed to excessive radiation.The 85% stenosed target lesion was located in a severely tortuous and mildly calcified vessel, with a 90% bend.Following pre-dilation with a 2.0 x 12 emerge balloon, a 2.25 x 12 synergy drug-eluting stent was advanced but failed to cross the lesion.This caused a significant delay of the procedure which resulted to excessive radiation exposure of the patient.No further information is available.

• 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: 10536093
• Report Number: 2134265-2020-11653
• Device Sequence Number: 16438599
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 05/07/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023811962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 81