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

Model Number	H7493941824450
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since the event date was asked but not available as per account.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in a coronary artery.A 4.50 x 24mm synergy? xd drug-eluting stent was advanced for treatment.Prior to inflation of the stent delivery balloon, the technician pulled negative on the non-boston scientific inflation device and observed blood filling the device.The stent system was removed, and pinhole was observed in the balloon material.The procedure was completed with a new synergy stent.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since the event date was asked but not available as per account.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: synergy xd mr us 4.50 x 24 mm stent delivery system (sds) was returned for analysis.A visual and tactile inspection identified multiple kinks along the hypotube shaft.Microscopic analysis identified no signs 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 port exchange was twisted, and a pinhole was identified when attempting to inflate.Bumper tip showed no signs of distal tip damage.During the wire insertion testing, the device could not be loaded on a 0.014-inch test guidewire as resistance was felt directly at the twisted port exchange.Leakage testing was performed by attaching the device to an encore inflation unit and an attempt to inflate the balloon however a leak was identified at the twisted port exchange.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in a coronary artery.A 4.50 x 24 mm synergy? xd drug-eluting stent was advanced for treatment.Prior to inflation of the stent delivery balloon, the technician pulled negative on the non-boston scientific inflation device and observed blood filling the device.The stent system was removed, and pinhole was observed in the balloon material.The procedure was completed with a new synergy stent.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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23636637
• Report Number: 2124215-2025-85944
• Device Sequence Number: 13357230
• Product Code: NIQ
• UDI-Device Identifier: 08714729981213
• UDI-Public: (01)08714729981213(17)270414(10)36361145
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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 Model Number: H7493941824450
• Device Catalogue Number: H7493941824450
• Device Lot Number: 0036361145
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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