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

Model Number	H7493941808350
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.During unpacking of a 3.50 x 8mm synergy xd drug-eluting stent, it was noted that a white particle was present on the tip of the stent.The procedure was completed via alternative method.There were no patient complications reported.
Event or Problem Description
It was reported that device contamination occurred.During unpacking of a 3.50 x 8mm synergy xd drug-eluting stent, it was noted that a white particle was present on the tip of the stent.The procedure was completed via alternative method.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr ous 3.50 x 8mm stent delivery system (sds), was returned for analysis, device returned inside biohazard bag no issues or fm visible inside the bag or on the stent inside the bag.The following attributes were examined: stent profile: a visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.There was no fm identified on the stent.Balloon profile: 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.Tip profile: a visual and microscopic examination of the bumper tip showed no signs of distal tip damage.Hypotube profile: a visual and tactile examination of the hypotube shaft found multiple kinks.Shaft polymer extrusion profile: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15760002
• Report Number: 2124215-2022-45825
• Device Sequence Number: 15009276
• Product Code: NIQ
• UDI-Device Identifier: 08714729981022
• UDI-Public: 08714729981022
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 07/10/2024
• Device Model Number: H7493941808350
• Device Lot Number: 0029803979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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