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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Agent ide study: it was reported that angina and in-stent restenosis occurred.On (b)(6) 2020, a 3.00 mm x 8 mm synergy stent was implanted in the proximal left circumflex artery (lcx) and a 3.00 x 12mm synergy stent was implanted in the proximal rca.On (b)(6) 2020, severe in-stent restenosis (isr) was noted in the proximal rca.A 2.75 x 28mm synergy stent and a 2.75 x 12mm synergy stent were implanted in the proximal to mid rca to treat the restenosis.On (b)(6) 2021, the subject presented with stable angina and was randomized into the agent ide study and index procedure was performed the same day.Heparin or other antithrombotic medication were administered at the time of index procedure.The isr of the 3.0 x 8mm synergy stent at the proximal lcx was treated with balloon angioplasty.On the same day, the 3.00 x 10mm isr of the mid rca (where the 2.75 x 28mm synergy and 2.75 x 12mm synergy stents were located) was also treated.The target lesion was predilated with a 2.5 mm x 15 mm balloon with 10% residual stenosis and timi flow 3.Following pre-dilation, the lesion was successfully treated with 3.50 mm x 12 mm study device with 10% residual stenosis and timi flow 3.Post dilation was not performed.The subject experienced confusion, diarrhea, acute kidney injury, metabolic acidosis, and vertigo not considered related to the devices.On (b)(6) 2021, the subject was discharged on aspirin and clopidogrel.

• 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
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13809116
• MDR Text Key: 287788827
• Report Number: 2134265-2022-02840
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 87 YR
• Patient Sex: Male
• Patient Race: Black Or African American