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

Lot Number	0030793686
Medical Device Problem Codes	Positioning Failure (1158); Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent placement failed and the patient experienced pain.Two synergy xd were advanced for treatment, but failed to "hook" and had to be pulled out.Per the patient, inadequate sedation was provided and excruciating pain during removal of the stents was experienced.A third synergy xd was successfully placed to complete the procedure.
Additional Manufacturer Narrative
Correction: h6 device code.
Event or Problem Description
It was reported that stent placement failed and the patient experienced pain.Two synergy xd were advanced for treatment, but failed to "hook" and had to be pulled out.Per the patient, inadequate sedation was provided and excruciating pain during removal of the stents was experienced.A third synergy xd was successfully placed to complete the procedure.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18499295
• Report Number: 2124215-2024-01393
• Device Sequence Number: 8125441
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 01/02/2025
• Device Lot Number: 0030793686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown