MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Angina (1710); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/12/2024

Event Type  Injury  

Event Description

Agent ide study.It was reported that thrombosis occurred.On (b)(6) 2023, the subject presented with symptoms of recurrent angina and was diagnosed with severe ostial right coronary artery (rca) stenosis.At the time of event, the subject was on aspirin and clopidogrel.Diagnostic coronary angiography revealed 90% in-stent restenosis at the proximal rca.Revascularization was recommended.The 90% severe ostial rca stenosis was treated with percutaneous coronary intervention (pci) procedure using a 5.00 mm x 16 mm synergy megatron drug eluting stent and 5.00mm x 12mm nc emerge balloon catheter.Post revascularization, 20 % residual stenosis with timi flow 3 was noted.The event was considered recovered/resolved.On (b)(6) 2024, the subject underwent target lesion revascularization.At the time of event, the subject was on aspirin and clopidogrel.Diagnostic coronary angiography revealed thrombosis at the target lesion with 95 % in-stent restenosis at proximal rca.The 95 % in-stent restenosis at proximal rca was treated with balloon angioplasty and drug eluting stent.Post revascularization, 0% residual stenosis was noted with timi flow 3.The event was considered to be resolved/recovered.

Event Description

Agent ide study it was reported that thrombosis occurred.On (b)(6) 2023, the subject presented with symptoms of recurrent angina and was diagnosed with severe ostial right coronary artery (rca) stenosis.At the time of event, the subject was on aspirin and clopidogrel.Diagnostic coronary angiography revealed 90% in-stent restenosis at the proximal rca.Revascularization was recommended.The 90% severe ostial rca stenosis was treated with percutaneous coronary intervention (pci) procedure using a 5.00 mm x 16 mm synergy megatron drug eluting stent and 5.00mm x 12mm nc emerge balloon catheter.Post revascularization, 20 % residual stenosis with timi flow 3 was noted.The event was considered recovered/resolved.On (b)(6) 2024, the subject underwent target lesion revascularization.At the time of event, the subject was on aspirin and clopidogrel.Diagnostic coronary angiography revealed thrombosis at the target lesion with 95 % in-stent restenosis at proximal rca.The 95 % in-stent restenosis at proximal rca was treated with balloon angioplasty and drug eluting stent.Post revascularization, 0% residual stenosis was noted with timi flow 3.The event was considered to be resolved/recovered.It was further reported that on (b)(6) 2024, the subject was presented for cardiac catheterization with possible pci in the setting of canadian cardiovascular society (ccs) iii angina symptoms.Intravascular ultrasound (ivus) revealed under-expansion of the previously placed stent due to recoil at the target lesion.The 95% in-stent restenosis at proximal rca was treated with percutaneous coronary intervention.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18852442
• MDR Text Key: 337068006
• Report Number: 2124215-2024-13367
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/05/2024
• 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: 47 YR
• Patient Sex: Male
• Patient Race: White