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

Model Number	H7493941820250
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Codes	Chest Pain (1776); Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered which led to patient complications and a shaft break.The patient presented not doing well and already in cardiac shock.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified obtuse marginal (om) branch.The physician had to stent the lesion proximal to distal.The second stent, a 2.50 x 20mm synergy xd, was deployed to an unknown pressure below rated burst pressure.Post stent deployment, the stent delivery system (sds) balloon would not deflate and was stuck in the artery.More than 10 minutes was spent trying to deflate the balloon and while the balloon remained inflated, the patient experienced chest pain and coded.Multiple stiff wires and snares were used in an attempt to pop the balloon.When these attempts were unsuccessful, the wire and sds were pulled, but both the wire and sds shaft snapped; the sds shaft broke right before the proximal markerband.The wire fragments were able to be snared but some of the sds remained inside the patient causing the om branch to occlude.Because the patient had presented for the procedure already in cardiac shock, surgery to remove the device fragment was not an option.Additional information was requested on the patient outcome.

• 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: 13999379
• Report Number: 2134265-2022-03184
• Device Sequence Number: 4908694
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 06/09/2023
• Device Model Number: H7493941820250
• Device Lot Number: 0027535510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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: Required Intervention
• Patient Sex: Unknown