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

Lot Number	0031089004
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent migration occurred.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified right coronary artery (rca).A 3.50 x 48mm synergy drug-eluting stent (des) was selected for treatment.The physician deployed the stent and inflated for 20 seconds before deflation.Post-dilatation was not performed.When pulling the non-boston scientific (bsc) wire back, the stent detached from the vessel and the entire stent came back on the wire.The synergy stent was completely removed from the patient.No other additional equipment was present in the vessel and no accidental movement occurred while inside the patient.The procedure was completed with a non-bsc stent.No patient complications were reported.
Event or Problem Description
It was reported that stent migration occurred.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified right coronary artery (rca).A 3.50 x 48mm synergy drug-eluting stent (des) was selected for treatment.The physician deployed the stent and inflated for 20 seconds before deflation.Post-dilatation was not performed.When pulling the non-boston scientific (bsc) wire back, the stent detached from the vessel and the entire stent came back on the wire.The synergy stent was completely removed from the patient.No other additional equipment was present in the vessel and no accidental movement occurred while inside the patient.The procedure was completed with a non-bsc stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.50 x 48mm stent delivery system (sds) was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.The delivery system was not returned.Examination of the stent revealed stent struts were stretched and damaged.The stent outer diameter (od) was not taken due to the damage.

• 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: 17908572
• Report Number: 2124215-2023-51345
• Device Sequence Number: 7543137
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: 08714729985235
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 11/17/2023

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: 02/07/2025
• Device Lot Number: 0031089004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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 Age: 77 YR
• Patient Sex: Male