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

Model Number 10621

Device Problem Obstruction of Flow (2423)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 08/09/2021

Event Type  Injury  

Event Description

Same case as pr id# (b)(4).(b)(6) registry.It was reported that unstable angina pectoris and restenosis in right crown stent occurred.In (b)(6) 2020, the subject presented with stable angina and was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion 1 was located in the proximal right coronary artery (rca) extending up to distal rca with 80 % stenosis and was 49 mm long with a reference vessel diameter of 3.0 mm.The target lesion 1 was treated with pre-dilatation and placement of 2.75 mm x 28 mm overlapped with 3.00 x 28 mm synergy stents system.Post-dilatation was performed with 0% residual stenosis.Two days later, the subject was discharged on clopidogrel.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.The subject was also diagnosed with stenosis in right crown stent.Intracoronary angiography, intracoronary drug therapy, internal coronary artery resection, intravascular ultrasound (ivus), percutaneous transluminal coronary angioplasty was performed along with drug balloon dilation (target vessel revascularization - tvr) to treat the event.At the time of reporting the outcome of the event was considered to be recovering and resolving.Three days later, the subject was discharged on clopidogrel.

• Brand Name: SYNERGY
• Type of Device: 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: 12808164
• MDR Text Key: 280880282
• Report Number: 2134265-2021-13936
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0025051379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Male