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

Model Number	H7493942832350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) study.It was reported that a perforation occurred.On (b)(6) 2021, the index procedure was performed.The 100% stenosed target lesion was located in the proximal right coronary artery (rca) extending to the first right posterolateral branch (1st rpl) and was 90mm long, with a reference vessel diameter of 4mm.The target lesion was predilated with 2.5mm largest balloon with maximum inflation pressure of 14mm using ivus.The lesion was treated with the placement of a 3.50 mm x 32 mm study stent.Post dilatation was performed with a 4mm balloon inflated to maximum pressure of 18mm.Timi flow was 0, with a 100% residual stenosis.A perforation was noted.However, no thrombus and abrupt closure were noted post procedure.No further complications were reported in relation to this event.On (b)(6) 2021, the subject was discharged on dual antiplatelet therapy.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12454737
• Report Number: 2134265-2021-11512
• Device Sequence Number: 11061385
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 12/02/2021
• Device Model Number: H7493942832350
• Device Lot Number: 0026505660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR