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

Model Number	H7493941832300
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported 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 but had difficulty crossing the lesion.The stent got caught on the previous stent in the diagonal branch, dislodged, and floated down to the iliac.The physician was unable to snare the stent and a vascular surgeon was called.The vascular surgeon said where the stent landed would be okay so the procedure was completed using an alternate method.There were no patient complications and the patient fully recovered.
Event or Problem Description
It was reported 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 but had difficulty crossing the lesion.The stent got caught on the previous stent in the diagonal branch, dislodged, and floated down to the iliac.The physician was unable to snare the stent and a vascular surgeon was called.The vascular surgeon said where the stent landed would be okay so the procedure was completed using an alternate method.There were no patient complications and the patient fully recovered.It was further reported that resistance was encountered while passing through the previously implanted diagonal stent, but the stent was not touched.No pressure was applied to the delivery system balloon prior to the stent becoming dislodged.

• 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: 20610510
• Report Number: 2124215-2024-68228
• Device Sequence Number: 20669017
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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,Followup
• Report Date (Section B): 11/18/2024

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: 04/09/2026
• Device Model Number: H7493941832300
• Device Catalogue Number: H7493941832300
• Device Lot Number: 0033852445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/19/2024
• Date Device Manufactured: 04/09/2024
• 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