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

Model Number	10607
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent thrombosis and st-segment elevation myocardial infarction occurred.A 3.00 x 32 and two 3.00 x 38 synergy drug-eluting stents were implanted in the right coronary artery (rca).Six hours post stent implantation, the patient presented with chest pain symptoms after the aggrastat drip was discontinued.An angiogram was performed which indicated thrombus was present and intravascular ultrasound (ivus) indicated the stents were well apposed but were a little undersized.The physician post dilated with a 3.25 non-boston scientific balloon.No further complications were reported.The patient was fully recovered with a good prognosis after the procedure.
Event or Problem Description
It was reported that stent thrombosis and st-segment elevation myocardial infarction occurred.A 3.00 x 32 and two 3.00 x 38 synergy drug-eluting stents were implanted in the right coronary artery (rca).Six hours post stent implantation, the patient presented with chest pain symptoms after the aggrastat drip was discontinued.An angiogram was performed which indicated thrombus was present and intravascular ultrasound (ivus) indicated the stents were well apposed but were a little undersized.The physician post dilated with a 3.25 non-boston scientific balloon.No further complications were reported.The patient was fully recovered with a good prognosis after the procedure.It was further reported that the target lesion was 100% stenosed.The physician judged the artery to be a 3.0mm vessel; however, intravascular ultrasound (ivus) revealed that the vessel was 3.25mm.Additionally, it was noted that the stents were overlapped.Finally, it was noted that the physician did not state that the patient coming off aggrastat drip may have resulted in the thrombosis occurring.
Additional Manufacturer Narrative
F10.Device codes: updated from defective device to adverse event without identified device or use problem.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13232408
• Report Number: 2134265-2021-16450
• Device Sequence Number: 4554564
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 04/07/2023
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0027145402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Male