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

Model Number	H7493941838220
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 2.25 x 38mm synergy xd drug-eluting stent was selected for use in a percutaneous coronary intervention; however, it was noted that the stent came out of the package with struts broken in the middle.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that stent damage occurred.A 2.25 x 38mm synergy xd drug-eluting stent was selected for use in a percutaneous coronary intervention; however, it was noted that the stent came out of the package with struts broken in the middle.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: synergy xd mr us 2.25 x 38mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found stent damage.Stent struts in the mid-section were lifted and pulled distally.The undamaged stent od (outer diameter) was measured using snap gauge and the result was 0.0370" this is within max crimped stent profile measurement.The balloon cones were 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 microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12669059
• Report Number: 2134265-2021-13243
• Device Sequence Number: 4161280
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2021

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: 10/28/2022
• Device Model Number: H7493941838220
• Device Lot Number: 0026297612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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