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

Model Number	H7493941824250
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.The 80% stenosed target lesion was located in the mildly calcified and moderately tortuous mid right coronary artery (rca) which had moderate angulation.Pre-dilatation was performed with emerge and nc emerge balloon catheters.The physician then delivered 2.50 x 16 mm and 2.50 x 24 mm syergy xd stents with the aid of a 6f guidezilla extension catheter.Both stents were deployed without any issues and post-dilatation was performed using a 2.50 x 12 mm nc emerge balloon catheter.The patient was given 180mg brilinta medication and transferred to the recovery area.An hour later, the patient experienced hypertension and chest pain.An angiogram was performed which revealed thrombus within both stents which was evacuated using a non boston scientific device.Post-dilatation was performed again with a 2.50 x 12 mm nc emerge balloon and timi 3 flow was restored.The patient fully recovered.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11463961
• Report Number: 2134265-2021-02508
• Device Sequence Number: 3801403
• Product Code: NIQ
• UDI-Device Identifier: 08714729980827
• UDI-Public: 08714729980827
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 11/02/2022
• Device Model Number: H7493941824250
• Device Lot Number: 0026344299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR