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

Model Number 10605

Device Problem Positioning Problem (3009)

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Thrombosis (2100)

Event Date 09/26/2020

Event Type  Injury  

Event Description

It was reported that stent partial deployment, thrombosis, chest pain and elevated troponin occurred.On (b)(6) 2020, the 95% in-stent restenosed target lesion was located in the left anterior descending artery (lad).A 2.50 x 28 synergy drug-eluting stent was advanced for treatment.However, the patient experienced chest pain and acute stent thrombosis was noted in the mid lad and percutaneous transluminal coronary angioplasty (ptca) was performed.Three days later, the patient went to the emergency department and presented with chest pain and elevated troponin.Intravascular ultrasound showed that there was a malposition of the stent.Ptca was then performed with a non compliant balloon at high pressure.No further complications were reported and the patient was discharged home.

• 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: 10727326
• MDR Text Key: 212757472
• Report Number: 2134265-2020-14229
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024661654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2019
• 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
• Patient Age: 76 YR