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

Model Number	H7493941824300
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, partial deployment, and shaft break occurred.The target lesion was located in the obtuse marginal branch.The 3.00 x 24mm synergy xd stent was advanced for treatment.Upon inflation, the stent balloon ruptured leaving the stent partially deployed.When an attempt was made to remove the device, the catheter broke leaving the balloon and about 20cm of the shaft inside the patient.Wire placement was also lost.The patient was sent for emergency coronary artery bypass graft and the device portion retained in the patient was partially removed during surgery.
Event or Problem Description
It was reported that balloon rupture, partial deployment, and shaft break occurred.The target lesion was located in the obtuse marginal branch.The 3.00 x 24mm synergy xd stent was advanced for treatment.Upon inflation, the stent balloon ruptured leaving the stent partially deployed.When an attempt was made to remove the device, the catheter broke leaving the balloon and about 20cm of the shaft inside the patient.Wire placement was also lost.The patient was sent for emergency coronary artery bypass graft and the device portion retained in the patient was partially removed during surgery.It was further reported via medwatch 2601800000-2022-8003 that the patient presented for stent placement in 3 locations.On the 3rd stent placement, the balloon appeared to have ruptured.A cardiothoracic surgeon contacted and the patient taken to surgery.The catheter and ruptured balloon were removed from the vessel.The surgeon and procedural cardiologist examined the catheter and balloon and determined them to be intact.The patient taken to cardiovascular intensive care unit for recovery and was discharged home.

• 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: 13933217
• Report Number: 2134265-2022-03317
• Device Sequence Number: 20016453
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 10/11/2023
• Device Model Number: H7493941824300
• Device Lot Number: 0028240717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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: Life Threatening; Other; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White