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

Model Number	H7493941848300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stent fracture and thrombosis occurred.The patient presented with percutaneous coronary intervention.The right coronary artery (rca) was totally occluded, mildly tortuous and severely calcified.A 2.75 x 38 synergy stent was used in the distal rca and deployed at 14atm.The 3.0 x 48 synergy stent was moved proximal making sure it was overlapping, and was deployed at 14atm.Finally, a 3.0 x 12 stent was placed.The stent was post dilated using a 3.0 x 20 nc balloon at 14-20 atm.The wires and temporary pacer were removed.However, after a month, the patient returned with stent thrombosis.It was noted the 3.0 x 48 synergy stent was fractured at the distal portion, which was confirmed via angiogram.The device was not attempted to be removed, and the procedure was completed by placing another stent.The patient was fine.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17138099
• Report Number: 2124215-2023-29917
• Device Sequence Number: 14896361
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: 08714729985228
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/15/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2024
• Device Model Number: H7493941848300
• Device Lot Number: 0029761344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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: GUIDEWIRE USED: PILOT WIRE AND ROTAWIRE; INTRODUCER SHEATH: 7 FRENCH ART
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown