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

Model Number 10607

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 12/17/2021

Event Type  Injury  

Event 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 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, when intravascular ultrasound (ivus) was performed after occurrence of thrombus, ivus revealed that the vessel was 3.25mm.Additionally, it was noted that the stents overlapped with each other.The physician stated that aggrastat did not cause the thrombosis but thrombosis happened when aggrastat was discontinued.

Manufacturer Narrative

F10.Device codes: updated from defective device to adverse event without identified device or use problem.

• Brand Name: SYNERGY
• Type of Device: 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: 13232678
• MDR Text Key: 283670430
• Report Number: 2134265-2021-16449
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Male