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

Model Number	H7493941832250
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 2.50 x 32 mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with stent struts from mid to distal stent region lifted and pulled in all directions.The undamaged crimped stent outer diameter was measured by snap gauge and was within max crimped stent profile measurement.Examination of the tip via scope found damage to the distal end of the tip.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 tactile examination of the hypotube identified a break in the hypotube shaft located at 1mm distal to the distal end of the strain relief as well as multiple kinks along the length of the hypotube shaft.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.Examination of the hub and strain relief via scope did not identify any issues.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 16-mar-2021.It was reported that crossing difficulties were encountered.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment, but failed to cross the lesion.No patient complications were reported.However, returned device analysis revealed stent damage.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11633797
• Report Number: 2134265-2021-03771
• Device Sequence Number: 17030768
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 09/14/2022
• Device Model Number: H7493941832250
• Device Lot Number: 0026054871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1