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

Model Number 10604

Device Problem Obstruction of Flow (2423)

Patient Problems Arrhythmia (1721); Bradycardia (1751); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event 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
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8754434
• MDR Text Key: 149829083
• Report Number: 2134265-2019-06938
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• 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): Required Intervention