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

Lot Number	0030355448
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that premature deployment and difficulty in removal occurred, requiring additional intervention.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).Atherectomy and cutting balloons were used successfully without any complications.A 4.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, upon delivery, the operator bent the proximal end of the delivery hypotube while attempting to complete crossing the stent.The operator removed the device because of the inability to inflate the delivery system.Upon removal, air was sucked into the balloon because of the change in pressure, which in turn, partially inflated the device, adding to the inability to remove it.It was noted the proximal end of the delivery system broke at the bent area outside the guide catheter, leaving the stent and balloon inside of the stent, partially stuck in the ostium of the rca and in the aorta.All systems and wires were successfully removed via snare through the arteriotomy access site.The procedure was completed with a 2 4.0mm synergy xd and the patient was kept overnight for evaluation and was discharged the next day without any complications.

• 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: 17980754
• Report Number: 2124215-2023-58180
• Device Sequence Number: 2505292
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: 08714729985242
• 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: 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): 10/20/2023

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: 10/09/2024
• Device Lot Number: 0030355448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/20/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Male