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

Model Number	10600
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)
Date of Event	08/21/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The target lesion was located in the left anterior descending (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.
Additional Manufacturer Narrative
This event is a duplicate and has already been reported under emdr 2134265-2020-11969.
Event or Problem Description
It was reported that the patient died.The target lesion was located in the left anterior descending (lad) artery.Following pre-dilatation with a 3.00 x 12 apex balloon, a 3.00 x 8mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and the lad went down.The patient was sent to operating room for surgery but before they could get the patient on bypass, he expired.

• 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: 10544478
• Report Number: 2134265-2020-11970
• Device Sequence Number: 3135002
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 01/01/2022
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0024977244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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: Death