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

Model Number	H7493941824450
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with coronary artery disease and underwent a percutaneous coronary intervention.The target lesions were located in the circumflex (cx) and left anterior descending (lad) arteries.A 3.50 x 32 mm synergy megatron? drug-eluting stent (des) was deployed in the cx artery.Following deployment, the balloon failed to deflate and was difficult to remove.The physician attempted to apply additional negative pressure, but this was unsuccessful.The device had to be forcibly withdrawn, and the distal end of the balloon remained inflated.The physician then proceeded to deploy a stent in the distal lad, followed by placement of a 4.50 x 24 mm synergy? xd des in the proximal lad.During removal, similar difficulties were encountered.The device was removed with force, and the guidewire was inadvertently extracted along with it.Once outside the body, the physician had to pull the guidewire from the balloon catheter with force.Upon inspection, the proximal portion of the stent balloon was still inflated.The procedure was completed successfully, and no patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.H3: device analysis in progress.Results pending completion of investigation.
Additional Manufacturer Narrative
B5 device event or problem updated.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.H3: device analysis in progress.Results pending completion of investigation.
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with coronary artery disease and underwent a percutaneous coronary intervention.The target lesions were located in the circumflex (cx) and left anterior descending (lad) arteries.A 3.50 x 32 mm synergy megatron? drug-eluting stent (des) was deployed in the cx artery.Following deployment, the balloon failed to deflate and was difficult to remove.The physician attempted to apply additional negative pressure, but this was unsuccessful.The device had to be forcibly withdrawn, and the distal end of the balloon remained inflated.The physician then proceeded to deploy a stent in the distal lad, followed by placement of a 4.50 x 24 mm synergy? xd des in the proximal lad.During removal, similar difficulties were encountered.The device was removed with force, and the guidewire was inadvertently extracted along with it.Once outside the body, the physician had to pull the guidewire from the balloon catheter with force.Upon inspection, the proximal portion of the stent balloon was still inflated.The procedure was completed successfully, and no patient complications were reported.It was further reported that during the stent deployments the balloons were inflated a couple pressures over nominal and the user allowed for 2 to 3 seconds for deflation prior to attempting withdrawal of the device.
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with coronary artery disease and underwent a percutaneous coronary intervention.The target lesions were located in the circumflex (cx) and left anterior descending (lad) arteries.A 3.50 x 32 mm synergy megatron? drug-eluting stent (des) was deployed in the cx artery.Following deployment, the balloon failed to deflate and was difficult to remove.The physician attempted to apply additional negative pressure, but this was unsuccessful.The device had to be forcibly withdrawn, and the distal end of the balloon remained inflated.The physician then proceeded to deploy a stent in the distal lad, followed by placement of a 4.50 x 24 mm synergy? xd des in the proximal lad.During removal, similar difficulties were encountered.The device was removed with force, and the guidewire was inadvertently extracted along with it.Once outside the body, the physician had to pull the guidewire from the balloon catheter with force.Upon inspection, the proximal portion of the stent balloon was still inflated.The procedure was completed successfully, and no patient complications were reported.It was further reported that during the stent deployments the balloons were inflated a couple pressures over nominal and the user allowed for 2 to 3 seconds for deflation prior to attempting withdrawal of the device.
Additional Manufacturer Narrative
B5 device event or problem updated.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: a synergy xd mr us 4.50 x 24mm stent delivery system (sds) catheter was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified that there was stretching and kinking in the midshaft of the device.Microscopic analysis revealed that the stent was deployed during the procedure and not returned.Microscopic examination found that the inner lumen was bunched 6.6cm from the distal tip and both the inner and outer lumen was perforated 5.8cm from the tip.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.No inflation testing was performed due to the identified perforation of the lumen as the device would not inflate with the system breached.

• 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: 23469219
• Report Number: 2124215-2025-76120
• Device Sequence Number: 15683222
• Product Code: NIQ
• UDI-Device Identifier: 08714729981213
• UDI-Public: (01)08714729981213(17)260326(10)33783727
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/29/2025

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: 03/26/2026
• Device Model Number: H7493941824450
• Device Catalogue Number: H7493941824450
• Device Lot Number: 0033783727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 12/04/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/03/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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 Sex: Unknown