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

Lot Number	0031183601
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The patient presented with st-segment elevation myocardial infarction and underwent percutaneous coronary intervention.The target lesion was severely tortuous and moderately calcified.Following pre-dilation, a 2.25 x 38mm synergy xd drug-eluting stent was advanced for treatment.During procedure, the physician tried to cross the stent through a 6f telescope non-boston scientific guide extension but failed due to the stent was stuck in the artery.When trying to remove the stent and guide extension, the stent got damaged.The physician then decided to remove all the equipment and start over.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The patient presented with st-segment elevation myocardial infarction and underwent percutaneous coronary intervention.The target lesion was severely tortuous and moderately calcified.Following pre-dilation, a 2.25 x 38mm synergy xd drug-eluting stent was advanced for treatment.During procedure, the physician tried to cross the stent through a 6f telescope non-boston scientific guide extension but failed due to the stent was stuck in the artery.When trying to remove the stent and guide extension, the stent got damaged.The physician then decided to remove all the equipment and start over.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 38mm stent delivery system was returned for analysis.Visual, tactile, microscopic and dimensional analysis was performed on the device.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.The outer and inner lumen and tactile examination of the entire extrusion found no issues.Examination of the crimped stent via scope found evidence of stent damage with the struts being pulled from the proximal section and bunched at the mid-section.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.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.

• 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: 19489175
• Report Number: 2124215-2024-31958
• Device Sequence Number: 7164992
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: 08714729980773
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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: 02/26/2025
• Device Lot Number: 0031183601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 Sex: Unknown