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

Model Number	10604
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that acute stent thrombosis and st-segment elevation occurred.The patient was given tenecteplase (tnkase) and brilinta.The target lesion was located in the right coronary artery (rca).A 3.50x24mm synergy ii drug-eluting stent was implanted 80 minutes after administration of tnkase.However, electrocardiogram showed st- segment elevation 67 minutes after stent placement.The patient was sent back to lab and it was noted that the implanted stent in the rca was 100%occluded due to a thrombus from undetermined site.Additional heparin was given and a stent was placed and the procedure was completed.The patient was reported with mild depressed right ventricular function.No further 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: 8749526
• Report Number: 2134265-2019-06934
• Device Sequence Number: 1998890
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023040349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Required Intervention