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

Model Number	10604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100); Vascular Dissection (3160)
Date of Event	12/28/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that dissection, thrombosis, and death occurred.A percutaneous coronary intervention (pci) of the left anterior descending artery (lad) was performed.Heparin was used to anti-coagulate the patient.A 3.00 x 38 synergy stent was placed in the mid lad.Following the placement of the first stent, a2.50 x 24 synergy stent was placed distally, but overlapping the first stent.A 3.50 x 16 synergy stent was then placed proximally and overlapping the first stent.Prior to the first stent placement, there was a fairly large dissection of the mid-lad.It was noted that this was assessed to have occurred during lesion preparation.It was further noted that there was a large diagonal branch in mid-lad which kept closing off, and there likely was a thrombus forming during the procedure.The patient became unstable as the procedure went on, compressions were started, but the patient died.

• 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: 8278530
• Report Number: 2134265-2019-00352
• Device Sequence Number: 16532724
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022650373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/25/2019
• 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