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

Model Number	H7493941832300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch# (b)(4) that stent dislodgement occurred.The target lesion was located in the left anterior descending artery.A 3.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the stent came off the balloon in the left main.A 6f non- boston scientific guide extension catheter was used to remove the dislodged stent.During removal of the stent, the initial wiring was threaded through a strut on the left circumflex stent (lcx) and resulted in the unintended removal of the lcx stent.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12367804
• Report Number: 2134265-2021-10675
• Device Sequence Number: 4333233
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 02/02/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0026820399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR