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

Model Number	H7493941828450
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.50 x 28mm synergy xd drug-eluting stent was advanced through a non-boston scientific guide catheter.However, during introduction, advancing difficulty was encountered and the device broke mid-shaft.The device was pulled out and the procedure was completed with another synergy xd drug-eluting stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd 4.50 x 28mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located approximately 44cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.The device could be loaded on a test guidewire and guide catheter without issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 4.50 x 28mm synergy xd drug-eluting stent was advanced through a non-boston scientific guide catheter.However, during introduction, advancing difficulty was encountered and the device broke mid-shaft.The device was pulled out and the procedure was completed with another synergy xd drug-eluting stent.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15869211
• Report Number: 2124215-2022-49144
• Device Sequence Number: 17447729
• Product Code: NIQ
• UDI-Device Identifier: 08714729981220
• UDI-Public: 08714729981220
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 06/21/2023
• Device Model Number: H7493941828450
• Device Lot Number: 0027635993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - 6F CONVEY AL1; GUIDE CATHETER - 6F CONVEY AL1
• Patient Sex: Unknown