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

Lot Number	0030366613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969); Obstruction/Occlusion (2422)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that occlusion occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 2.25 x 28mm and 2.25 x 16mm synergy xd drug-eluting stents were deployed in the circumflex artery and posterolateral descending artery.The patient was wheeled to post operation and complained of chest pain and had st-elevation in both lateral and inferior leads.The patient was then brought back to the laboratory, re-catheterized and it was observed that both stents were no longer patent.The patient also experienced a complication of myocardial infarction and ischemia.The procedure was completed successfully.The physician states that he does not believe the patient processes plavix efficiently and was changing to brilinta.The patient was expected to fully recover.
Event or Problem Description
It was reported that occlusion occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 2.25 x 28mm and 2.25 x 16mm synergy xd drug-eluting stents were deployed in the circumflex artery and posterolateral descending artery.The patient was wheeled to post operation and complained of chest pain and had st-elevation in both lateral and inferior leads.The patient was then brought back to the laboratory, re-catheterized and it was observed that both stents were no longer patent.The patient also experienced a complication of myocardial infarction and ischemia.The procedure was completed successfully.The physician states that he does not believe the patient processes plavix efficiently and was changing to brilinta.The patient was expected to fully recover.It was further reported that patient was sent back to the laboratory room and percutaneous coronary intervention was performed.

• 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: 19264466
• Report Number: 2124215-2024-26905
• Device Sequence Number: 15106939
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• 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,Followup
• Report Date (Section B): 06/04/2024

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: 10/09/2024
• Device Lot Number: 0030366613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female