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

Lot Number	0029931639
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break caused the procedure's cancellation.The 75% stenosed target lesion was located in the left anterior descending artery (lad).A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the shaft broke and due to the significant amount of contrast used, the physician aborted the procedure.There were no patient injuries reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 3.50 x 12mm stent delivery system (sds), was returned for analysis.A visual/tactile inspection and microscopic and dimensional analyses were completed.Multiple kinks were noted along the hypotube shaft.A break was noted in the midshaft and in the lasercut region.A jagged tear was identified in the distal extrusion.The tear stretched from the port site and extended distally for a total length of 23mm.Stent struts were lifted at the proximal section, but the stent was secured between the distal and proximal markerband.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The crimped stent od (outer diameter) was measured by snap gauge and the result was within max crimped stent profile measurement.
Event or Problem Description
It was reported that a shaft break caused the procedure's cancellation.The 75% stenosed target lesion was located in the left anterior descending artery (lad).A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, the shaft broke and due to the significant amount of contrast used, the physician aborted the procedure.There were no patient injuries reported.

• 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: 18793253
• Report Number: 2124215-2024-09846
• Device Sequence Number: 15379128
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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): 04/18/2024

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: 07/26/2024
• Device Lot Number: 0029931639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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 Sex: Unknown