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	Chest Pain (1776); Thrombosis/Thrombus (4440)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that acute stent thrombosis and chest pain occurred.Two 3.00 x 38 mm synergy xd drug-eluting stents were implanted in the patient successfully with no issues.Intravascular ultrasound (ivus) showed the mid left anterior descending (lad) vessel measured 3.5 mm and the first stent was implanted about 20 mm from the ostium.The stent balloon was taken up to 16 atm which put the stent at a 3.25 mm.The ramus artery measured at 3.00 mm and the second stent was implanted.Ivus also showed the stent touching all the walls of the mid lad due to plaque buildup in the area stented.Later that night the patient had chest pain, and electrocardiogram (ekg) changes.They were deemed a st-elevation myocardial infarction (stemi) and taken back to the catheterization lab where they found the stents were thrombosed.They were ballooned and flow was restored.The next day, the patient had another stemi and had to be taken back to the catheterization lab where the stents were thrombosed a second time.The third time the patient was taken back to the catheterization lab, ivus was performed, and the stents looked fully expanded with no dissection, nothing was visually apparent to have caused the clotting of the stents.The stent in the lad was inflated to a full 3.5 mm with a balloon.After this was done, there was a small non-flow limiting dissection at the distal end of the lad stent, but no additional stents were placed.After the third attempt the stents have remained open.Prior to discharge, the patient was put on a treadmill to assess if he would develop any chest pain.He tolerated it well and had an ejection fraction of 70%.Then patient was on brillinta and was tested to make sure the antiplatelet was effective.It was working the way it should be but the physician decided to switch the patient to effient and low dose xarelto.Furthermore, the patient had elevated homocysteine levels.The patient was to be discharged and sent home a with life vest.No further patient complications were reported as a result of this event.

• 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: 18051923
• Report Number: 2124215-2023-60335
• Device Sequence Number: 8077150
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

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?: 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: 10/04/2023
• Initial Report FDA Received Date: 11/01/2023
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown