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	Arrhythmia (1721); Bradycardia (1751); ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	04/22/2019
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 aspirin, heparin and brilinta.The target lesion was located in the right coronary artery.A 4.00x24mm synergy ii drug-eluting stent was implanted 6 minutes after administration of weight based heparin and brilinta given 3 minutes after stent placement.However, follow-up electrocardiogram showed st- segment elevation 57 minutes following stent placement.The patient was sent back to lab and it was noted that the implanted stent was occluded.A second stent was placed, integrilin and angiomax were started and completed the procedure.The patient was transferred to intensive care unit and was discharged with no further patient complications reported.Follow-up clinic visit stated that the patient was noted to have sinus bradycardia with first- degree atrioventricular block and evidence of inferior infarct.

• 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: 8754434
• Report Number: 2134265-2019-06938
• Device Sequence Number: 14052990
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 09/18/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022718218
• 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: 07/02/2019
• 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