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

Model Number	H7493941820400
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch (b)(4) that failure to deflate occurred.A 4.00 x 20mm synergy xd drug-eluting stent was positioned and deployed in the vessel.After deployment, the delivery balloon failed to recapture/deflate after upwards of two minutes.Negative pressure was drawn on the inflation device multiple times but it did not work to deflate the balloon.No further event details were provided.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 20mm was returned for analysis inserted through a 6french guide catheter.A visual and tactile examination of the exposed hypotube (the section not inserted through the guide catheter), identified multiple kinking along the length of the hypotube.A visual examination of the guide catheter noted that the guide was kinked and flattened at multiple locations along its length.A microscopic examination of the balloon, which was exiting out from the tip of the guide catheter, did not identify any tears in the balloon material.The balloon exhibited signs of having been inflated and was not refolded.Device to device interaction testing was performed by attempting to inflate the balloon without success.A vacuum was applied but the balloon did not change its profile (no refold).During an attempt to remove the device from the guide catheter, a break occurred in the hypotube.The break was located at 55.9cm from strain relief.The distal section of the break, including the balloon remained in the guide and could not be removed.Multiple attempts to remove the device failed.
Event or Problem Description
It was reported via medwatch (b)(4) that failure to deflate occurred.A 4.00 x 20mm synergy xd drug-eluting stent was positioned and deployed in the vessel.After deployment, the delivery balloon failed to recapture/deflate after upwards of two minutes.Negative pressure was drawn on the inflation device multiple times but it did not work to deflate the balloon.No further event details were provided.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20698253
• Report Number: 2124215-2024-69082
• Device Sequence Number: 3714540
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 03/04/2026
• Device Model Number: H7493941820400
• Device Catalogue Number: H7493941820400
• Device Lot Number: 0033656358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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 Age: 59 YR
• Patient Sex: Male