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

Model Number H7493941808350

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 307039519
• Report Number: 2124215-2022-45825
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981022
• UDI-Public: 08714729981022
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941808350
• Device Lot Number: 0029803979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1