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

Model Number	H7493941832300
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as stated on the email that the case was on (b)(6) 2021; however, event date should not be prior to notification date.
Event or Problem Description
It was reported that device entrapment occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use; however, the stent would not move over the wire.The procedure was completed with a non-boston scientific device.There were no patient complications reported and the patient was fine.
Event or Problem Description
It was reported that device entrapment occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use; however, the stent would not move over the wire.The procedure was completed with a non-boston scientific device.There were no patient complications reported and the patient was fine.It was further reported that the strut was bent and the device was not stuck on wire as what was previously reported.
Additional Manufacturer Narrative
Corrections: (b3) date of event updated from (b)(6) 2021 to (b)(6) 2021.(b5) desccribe event or problem updated.(h6) device code: entrapment of device initially reported corrected to material deformation and difficult to advance.

• 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: 11822630
• Report Number: 2134265-2021-05776
• Device Sequence Number: 1061030
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 02/02/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0026820399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1