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

Lot Number	0032340396
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft damage occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 20mm snergy xd drug-eluting stent was advanced for treatment.During insertion, when loading the stent onto the wire, the wire popped out where the stent balloon was attached to the shaft.The balloon was never inflated, and no visible hole was noted on the balloon.An alternate device was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 20mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.No damages were identified in hypotube shaft.The inner lumen was stretched and prolapsed 6.5cm proximal from the bumper tip of the device.The inner lumen was punctured with the outer lumen protruding just 4mm from the inner lumen damage.The outer lumen was not punctured.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The distal bumper tip was flared.
Event or Problem Description
It was reported that shaft damage occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 20mm snergy xd drug-eluting stent was advanced for treatment.During insertion, when loading the stent onto the wire, the wire popped out where the stent balloon was attached to the shaft.The balloon was never inflated, and no visible hole was noted on the balloon.An alternate device was used to complete the procedure.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19449195
• Report Number: 2124215-2024-33349
• Device Sequence Number: 8747717
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 07/23/2024

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: 08/15/2025
• Device Lot Number: 0032340396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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