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); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 07/09/2021

Event Type  Injury  

Event Description

It was reported that restenosis occurred.On (b)(6) 2018, three synergy drug eluting stents were placed at the proximal to mid left anterior descending (lad).On (b)(6) 2021, angiography revealed the mid lad had 100% in-stent restenosis (isr) of the previously deployed synergy drug eluting stents which was treated with atherectomy and percutaneous transluminal coronary angioplasty (ptca).On (b)(6) 2022, the subject presented with unstable angina and the index procedure was performed on the same day.Heparin or other antithrombotic medication were administered at the time of index procedure.The subject was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours), at the time of index procedure.Angiography revealed 90% isr of the previously deployed synergy drug eluting stents.The target lesion was located at the mid lad and was 15 mm long with a reference vessel diameter of 3.1 mm.The target lesion was predilated using a 3.00 mm x 15 mm non-boston scientific balloon and laser atherectomy resulting in 0% residual stenosis with timi flow of 3.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 20 mm nc emerge study device, with 0% residual stenosis and timi flow of 3.The subject was discharged on aspirin and clopidogrel.

Event Description

It was reported that restenosis occurred.On (b)(6) 2018, three synergy drug eluting stents were placed at the proximal to mid left anterior descending (lad).On (b)(6) 2021, angiography revealed the mid lad had 100% in-stent restenosis (isr) of the previously deployed synergy drug eluting stents which was treated with atherectomy and percutaneous transluminal coronary angioplasty (ptca).On (b)(6) 2022, the subject presented with unstable angina and the index procedure was performed on the same day.Heparin or other antithrombotic medication were administered at the time of index procedure.The subject was on a prior regimen of aspirin (>= 72 hours) and antiplatelet medication other than aspirin (>= 72 hours), at the time of index procedure.Angiography revealed 90% isr of the previously deployed synergy drug eluting stents.The target lesion was located at the mid lad and was 15 mm long with a reference vessel diameter of 3.1 mm.The target lesion was predilated using a 3.00 mm x 15 mm non-boston scientific balloon and laser atherectomy resulting in 0% residual stenosis with timi flow of 3.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 20 mm nc emerge study device, with 0% residual stenosis and timi flow of 3.The subject was discharged on aspirin and clopidogrel.It was further reported that the subject presented to the hospital for follow up for cardiac history on (b)(6) 2023.The subject complained of daily chest pain for several months and described the chest pain as a heavy chest pressure that progressed to pain and dizziness, with near loss of vision.During past episodes, the symptoms were resolved with nitroglycerin.The subject was recommended for a left heart catheterization which was planned for a later date.On (b)(6) 2023, the subject presented to the hospital for the diagnostic coronary angiography.The 99% stenosis at the 1st diagonal was successfully treated using a 2.00 mm x 12 mm non-boston scientific balloon, a 2.50 mm x 12 mm non-boston scientific balloon and a 2.00 mm x 10 mm wolverine monorail cutting balloon.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17980645
• MDR Text Key: 326235499
• Report Number: 2124215-2023-58449
• 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,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 12/04/2023
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White