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

Model Number	10607
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/13/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported a patient death had occurred.A percutaneous coronary intervention procedure was being performed in the right coronary artery.There was an occlusion in the middle portion of the artery and a dissection in the proximal portion of the artery.One stent was placed to treat the dissection and another was needed to treat the rest of the artery.With the proximal stent being placed in addition to the tortuosity of the vessel, the two synergy drug eluting stents (2.5mm x 38mm and 3mm x 38mm) could not pass through the existing stent and subsequently, the end of the stents were crushed.The procedure was completed with different sized synergy stents to cover the entire right coronary artery.However, the patient died due to other circumstances.

• 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: 8023893
• Report Number: 2134265-2018-62392
• Device Sequence Number: 1640626
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/31/2018

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: 03/12/2019
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0021890368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death