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

Model Number	H7493941828300
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty removing a balloon, elevated st changes in an ekg occurred, and failure to deflate a balloon occurred.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00 x 28mm synergy xd was advanced, the balloon was inflated for 11 seconds, and the stent deployed in the lesion.It was noted that the balloon was initially slow to inflate.Upon deflation, the proximal end of the balloon would not come down.The indeflator was pulled negative, but the proximal end of the balloon remained inflated, which caused st changes in an ekg.An empty 20cc syringe was then attached to the stopcock, and was pulled negative, which allowed the balloon to deflate enough to remove it.It was noted that 30 seconds were attempted to deflate the balloon, and vacuum was held during withdrawal.After the balloon was removed, the device was inspected for kinks and defects.It was noticed that the hub was bent.It was noted that there were some mild bends in the delivery platform, but no kinks noted prior to removal.It was additionally noted that the balloon was partially inflated, as it did not fully deflate, even with the indeflator attached.The procedure was completed.No further patient complications resulted in relation to this event.
Event or Problem Description
It was reported that difficulty removing a balloon, elevated st changes in an ekg occurred, and failure to deflate a balloon occurred.The target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 3.00 x 28mm synergy xd was advanced, the balloon was inflated for 11 seconds, and the stent deployed in the lesion.It was noted that the balloon was initially slow to inflate.Upon deflation, the proximal end of the balloon would not come down.The indeflator was pulled negative, but the proximal end of the balloon remained inflated, which caused st changes in an ekg.An empty 20cc syringe was then attached to the stopcock, and was pulled negative, which allowed the balloon to deflate enough to remove it.It was noted that 30 seconds were attempted to deflate the balloon, and vacuum was held during withdrawal.After the balloon was removed, the device was inspected for kinks and defects.It was noticed that the hub was bent.It was noted that there were some mild bends in the delivery platform, but no kinks noted prior to removal.It was additionally noted that the balloon was partially inflated, as it did not fully deflate, even with the indeflator attached.The procedure was completed.No further patient complications resulted in relation to this event.It was further reported that the balloon was able to deflate by pulling back with an empty 20cc syringe.A 6fr guide catheter was used during the procedure.No resistance was noted during the procedure.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13087706
• Report Number: 2134265-2021-16119
• Device Sequence Number: 17570574
• Product Code: NIQ
• UDI-Device Identifier: 08714729980995
• UDI-Public: 08714729980995
• 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: 2021
• 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): 01/19/2022

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: 03/22/2023
• Device Model Number: H7493941828300
• Device Lot Number: 0027045583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female