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

Model Number	10618
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Death
Event or Problem Description
Evolve lv_xlv study: it was reported that the subject died.In october 2020, the subject was enrolled in the clinical study and on the same day index procedure was performed.The target lesion was located in the saphenous vein graft (svg) to the right coronary artery (rca) with 75% stenosed lesion and was 16 mm long with a distal vessel diameter of 4.5 mm and timi flow of 3.The target lesion was treated with pre-dilation and placement of 4.50 mm x 16 mm study stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow of 3.On the following day, the subject was discharged on dual antiplatelet therapy.In december 2021, the subject expired.
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Additional Manufacturer Narrative
A1- patient identifier: (b)(6).
Event or Problem Description
Evolve lv_xlv study it was reported that the subject died.In (b)(6) 2020, the subject was enrolled in the clinical study and on the same day index procedure was performed.The target lesion was located in the saphenous vein graft (svg) to the right coronary artery (rca) with 75% stenosed lesion and was 16 mm long with a distal vessel diameter of 4.5 mm and timi flow of 3.The target lesion was treated with pre-dilation and placement of 4.50 mm x 16 mm study stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow of 3.On the following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, the subject expired.It was further reported that the subject died in the hospital due to unknown cause.Multiple attempts to obtain additional information were unsuccessful.

• Brand Name: SYNERGY
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15916109
• Report Number: 2124215-2022-49938
• Device Sequence Number: 4384228
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 05/30/2023

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: 02/09/2022
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0025228873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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: Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White