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

Model Number	H7493941824300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24mm synergy xd drug-eluting stent was selected for use but was found to have a frayed strut.No complications were reported and the patient was not harmed.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 24mm synergy xd drug-eluting stent was selected for use but was found to have a frayed strut.No complications were reported and the patient was not harmed.
Additional Manufacturer Narrative
Device evaluated by mfr.:synergy xd mr us 3.00 x 24mm stent delivery system was returned for analysis.An examination of the crimped stent identified proximal stent damage with the stent struts lifted from the crimped position.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks.A examination of the shaft polymer extrusion found no issues.An examination of the tip found no signs of damage.No other issues were identified during the product analysis.

• 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: 11567254
• Report Number: 2134265-2021-03867
• Device Sequence Number: 4150797
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 10/27/2022
• Device Model Number: H7493941824300
• Device Lot Number: 0026278622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1