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 ST Segment Elevation (2059); Thrombosis (2100)

Event Date 09/30/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent thrombosis occurred.The target lesion was located in the left anterior descending artery and diagonal branch.A 3.00 x 24mm and a 2.50x12mm synergy ii drug-eluting stents were implanted to treat the lesion and the procedure was completed.However, 24 hours after the procedure, the patient came back to the cath lab with st segment and troponins elevation and the stents were noted to have thrombosed.Repeat angiogram was performed and an attempt was made to re-wire the vessel but the wire would not cross the vessel.Post procedure prior to the st-elevation, the patient threw up their brilinta.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8024726
• MDR Text Key: 125670898
• Report Number: 2134265-2018-62502
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• 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: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022446236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• 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): Other
• Patient Age: 50 YR