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

Model Number	H7493942824350
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Vitalyst early feasibility study.It was reported that stent was not well apposed.During the index procedure, the 80% stenosis in the left ostial to proximal left anterior descending artery (lad) and in the lcx was treated by angioplasty using 2.50 mm non-compliant balloons followed by intravascular ultrasound imaging (ivus) of each vessel.Subsequently, severe calcification in the proximal lad and proximal lcx was treated with angioplasty using a 3.00 mm non-compliant balloon and a non-boston scientific lithotripsy balloon followed by angioplasty using a 3.50 mm wolverine cutting balloon.Two 3.50 mm x 24.00 mm synergy megatron des were implanted followed by proximal optimization technique using a 4.00 mm balloon.A proximal mal apposition noted in the lmca segment of the stent was post-dilated using a 5.00 mm balloon.In addition, a contained perforation was noted in the lmca which was treated by balloon angioplasty with serial inflations using a 4.00 mm ptca balloon which stopped all extravasations.Echocardiogram revealed good result with no pericardial effusion.Post intervention lesion assessment revealed, timi 3 flow and 0% residual stenosis.Estimated blood loss was noted to be 50 ml.The subject was transferred to the critical care unit where they remained hemodynamically stable with good perfusion markers.The subject was transferred to the floor for further management.The event was considered resolved and the subject continued dapt and metrprolol.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: 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: 21060440
• Report Number: 2124215-2024-82692
• Device Sequence Number: 8023042
• Product Code: NIQ
• UDI-Device Identifier: 08714729985693
• UDI-Public: 08714729985693
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2026
• Device Model Number: H7493942824350
• Device Catalogue Number: H7493942824350
• Device Lot Number: 0033840088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 04/03/2024
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White