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

Lot Number	0030733003
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	09/30/2023
Type of Reportable Event	Death
Event or Problem Description
Acurate ide study: it was reported that the patient died.On (b)(6) 2023, the subject was brought to the emergency department with chief complaints of acute chest pressure, confusion with altered mental status, dizziness, and nausea/emesis.The subject was diagnosed with inferior st elevation myocardial infarction.The subject received 324 mg aspirin as well as heparin bolus and was referred for immediate percutaneous coronary intervention (pci).Coronary angiography revealed a 99% stenosed ostium to proximal right coronary artery (rca) lesion.Owing to the need for rca intervention, due to bradycardia, hypotension and heart block, the subject was implanted with a temporary pacer.The vessel was pre-dilated with a 1.50 mm non-boston scientific (bsc), 2.00 mm emerge, 2.50 mm emerge, 2.50 mm nc emerge, and 3.00 mm nc emerge balloons.However, there was extensive recoil of the balloons.With each ballooning, the subject became profoundly hypotensive resulting in cardiogenic shock which required iv epinephrine, levodopa.The subject also became profoundly hypoxic and unresponsive which required transient chest compression.The subject was intubated in the cath lab, and a non-bsc heart pump was added for mechanical circulatory support to stabilize the subject to proceed pci.The lesions were treated with laser atherectomy, intravascular lithotripsy and with the aid of a non-bsc guide extension catheter, the vessel was stented with a 3.00 x 32 synergy drug-eluting stent (des) overlapped proximally with a 3.00 x 20 mm synergy des overlapping proximally with a 3.50 x 20 mm synergy megatron stent.There was timi-3 flow in the rca.The subject was later transferred to the critical care unit on high-dose inotropes and pressor and for further management.The subject remained significantly acidotic and hemodynamically unstable.After discussion with the family, the subject was transitioned to comfort measures.The subject was further extubated, the heart pump and pressors were discontinued due to the significant clinical decline and tenuous status despite significant medical intervention.On the same day, the subject was pronounced dead.Per the death certificate, the immediate cause of death was cardiogenic shock due to st elevation myocardial infarction and heart failure.Autopsy was not performed per death certificate.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18695923
• Report Number: 2124215-2024-06046
• Device Sequence Number: 18270042
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/13/2024

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
• Device Expiration Date: 12/11/2024
• Device Lot Number: 0030733003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1.50 MM MINI TREK BALLOON CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Patient Race: White