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

Model Number	10622
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Restenosis (4576)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study: it was reported that patient experienced unstable angina pectoris.In (b)(6) 2019, the subject was enrolled in the evolve 4.5/5.0 study and on the same day index procedure was performed.Target lesion #1 was located in saphenous vein graft (svg) extending from svg to obtuse marginal (om) with 80% stenosis and was 56 mm long with a distal vessel diameter of 4.5 mm.Target lesion #1 was treated with direct placement of two 4.5 mm x 32 mm study stents.The final residual stenosis was noted to be 0% with timi flow 3.Baseline electrocardiogram (ecg) revealed sinus bradycardia with axis deviation, st and t wave abnormality, consider anterolateral ischemia.The next day, subject was discharged on dual antiplatelet therapy.In (b)(6) 2022, post index procedure, subject was diagnosed with coronary artery disease involving native coronary artery with unstable angina pectoris.At the same time, subject did not experience shortness of breath, dyspnea on exertion, palpitations, heart racing or skipped beats, lower extremity edema, orthopnea, weakness, numbness or neurological symptoms, syncope or presyncope.Subject was well tolerating medications without any significant side effects and blood pressure well controlled at home.Subsequently, the subject underwent pre-operative ecg which revealed sinus bradycardia with marked sinus arrhythmia, non-specific intraventricular conduction delay, t wave abnormality, consider inferior ischemia, shortened qt wave.On the same day, subject underwent coronary angiography performed which revealed 95% stenosis noted in proximal graft lesion of vein graft to 1st marginal artery was revascularized by balloon dilation using 4 mm x 15 mm quantum apex nc balloon followed by placement of 4 mm x 30 mm drug -eluting stent.Post procedure dilation was performed using 4 mm x 15 mm quantum apex nc balloon and the residual stenosis was noted to be 0% with timi flow 3.Post intervention, no complication was found during the procedure and the event was considered recovered/resolved.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• 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: 14490843
• Report Number: 2134265-2022-05933
• Device Sequence Number: 14786263
• Product Code: NIQ
• UDI-Device Identifier: 08714729973393
• UDI-Public: 08714729973393
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023785535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: White