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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Hematoma (1884); Cardiogenic Shock (2262); Obstruction/Occlusion (2422)
Date of Event	03/05/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient was treated for a chronic total occlusion (cto) of the right coronary artery (rca).The cto procedure was initially successful, but a non-boston scientific interventional wire dissected the artery from the proximal rca to the proximal posterior descending artery (pda), which was confirmed with intravascular ultrasound (ivus).A 2.50x16mm, 3.00x28mm, 3.50x38mm, and 4.00x16mm synergy xd drug-eluting stents were deployed from the proximal pda to the ostial rca, respectively.There was slow flow / no reflow, and the right ventricle (rv) marginal and posterior lateral branch were occluded.The patient presented with st segment elevation, which was attributed to branch loss, and the flow was restored to timi 2 / 1.Cangrelor was used to treat the event.While the patient was placed in holding for an available intensive care unit (icu) bed for overnight observation, the patient coded, re-stabilized and returned to the cardiac catheterization laboratory.The rca was re-accessed, and the physician proceeded to place a balloon pump in the patient for support.The rv marginal intervention was attempted, and accessed, but no progress was made, and the physician opted to bail on the intervention.The posterolateral branch of the rca was accessed, ballooned, and was not stented.During the procedure, the patient was in and out of arrhythmias, but no shock nor cardiopulmonary resuscitation was needed.A temporary pacer was placed in the rv and the patient was intubated.A residual hematoma was noted in the right groin femoral access.A non-boston scientific 5.5 ventricular assist device was placed, and the patient was sent to surgery to resolve the hematoma.The physician was expecting the patient to recover, however, on the next day, the patient passed due to cardiogenic shock.

• Brand Name: SYNERGY XD
• 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: 18998062
• Report Number: 2124215-2024-15692
• Device Sequence Number: 16886427
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Race: Black Or African American