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

Model Number	H7493941816270
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent moved on the balloon and was difficult to remove.The patient presented with 50% stenosis and moderate calcification at the bifurcation of the left anterior artery/diagonal branch and 80% stenosis and moderate calcification at the mid diagonal branch.After treatment of the mid diagonal with a 1.25 rotapro burr, the 2.75 x 16mm synergy drug eluting stent (des) was advanced but could not cross the bifurcation.The stent was pulled back and a 6fr guidezilla guide extension catheter was inserted to help deliver the des.The stent was re-inserted and advanced through the guidezilla right up to the bifurcation.The des continued to be advanced but was unable to be delivered completely to the mid diagonal.An attempt was made to pull the des back but it got stuck on calcium and began to dislodge from the stent balloon.The stent was partially in the vessel and partially in the guidezilla.An nc balloon was delivered to crush the stent against the guidezilla and all devices were removed as a system.The procedure was completed using an alternate method or device.There were no patient complications.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12806885
• Report Number: 2134265-2021-14297
• Device Sequence Number: 11956489
• Product Code: NIQ
• UDI-Device Identifier: 08714729980889
• UDI-Public: 08714729980889
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: H7493941816270
• Device Lot Number: 0027850197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Patient Sex: Male