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

Model Number	H7493941824270
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient vessel obstruction occurred.A procedure was being performed using a synergy xd mr us 2.75 x 24mm device for treatment.During the procedure while inside the patient, it was noted that the balloon was only able to inflate about halfway.The stent was able to deploy on the proximal end, but remained attached to the balloon on the distal end.Upon closer inspection, it was noticed that the struts of the stent were stuck on the balloon.The indeflator had lost pressure and was noted to be spinning.Upon trying to remove the stent catheter using multiple ways, including inserting a non-boston scientific guide extension catheter over the balloon and using manual force to dislodge the struts from the balloon, the diagonal branch shut down and lost flow.The patient was then sent to surgery and the stent was successfully removed.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15925632
• Report Number: 2124215-2022-48572
• Device Sequence Number: 20140120
• Product Code: NIQ
• UDI-Device Identifier: 08714729980902
• UDI-Public: 08714729980902
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 12/06/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2024
• Device Model Number: H7493941824270
• Device Lot Number: 0029963783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male