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

Model Number	H7493941838300
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that removal difficulty and stent movement on the balloon occurred.The procedure was performed to treat a lesion in the non-tortuous right coronary artery (rca).An 8f non-boston scientific guide catheter and a 6f guidezilla ii guide extension catheter was used.The lesion was pre-dilated using multiple balloons, along with rotational atherectomy (rotablator) and intravascular lithotripsy (shockwave).A 3.00 x 38 mm synergy xd drug-eluting stent was advanced for deployment.During advancement, resistance was encountered as the stent interacted with the 6f guidezilla ii guide extension catheter.The stent was advanced past the guidezilla helix collar and inserted into the lesion.Upon attempted deployment, the balloon failed to inflate, and inflation was aborted.The stent could not be retracted into the guidezilla ii, and the entire system was removed together.Upon removal, the stent was visibly damaged and smashed on the balloon, with damage occurring during both advancement and withdrawal.Additional damage was noted on the guidezilla ii.Although the stent remained on the balloon, it had shifted from its original position.The system was successfully removed using the stent delivery system (sds), and the procedure was completed with a different device without any patient complications.
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.The device was returned for analysis.The device was received partially inserted through a 6fr guide catheter, with the crimped stent, balloon, and distal tip protruding from the distal end.Due to an inability to withdraw the device back through the guide catheter, it was instead pulled distally to expose the distal extrusion for evaluation.Visual and tactile inspection of the distal extrusion revealed that it had been stretched at multiple locations along its length.Microscopic examination confirmed these findings and further identified bunching or prolapse of the inner wire lumen approximately 8 cm from the distal tip.Examination of the crimped stent showed that the proximal section had been pulled distally along the balloon shaft, resulting in bunching.The proximal edge of the stent was located 10 mm distal to the proximal marker band, while the distal edge of the stent extended beyond and was stretched over the distal marker band.Microscopic evaluation of the balloon material revealed no signs of damage.The balloon remained tightly folded and did not appear to have been subjected to positive pressure, indicating it had not been inflated.Examination of the device tip showed that the distal edge was deformed, and a subsequent wire insertion test confirmed that it was not possible to pass a 0.014-inch guidewire through the inner wire lumen due to the tip damage.Attempts to remove the device from the guide catheter failed due to significant deformation along the stent, indicating device-to-device interaction during withdrawal.Dimensional analysis confirmed that the undamaged portion of the crimped stent had an outer diameter within specification for the maximum crimped stent profile measurement.Functional testing was conducted using a pre-tested encore inflation unit; however, multiple attempts to inflate the balloon to its rated burst pressure were unsuccessful.The failure to inflate was attributed to the damage sustained by the distal extrusion and the internal prolapse of the wire lumen, which obstructed the inflation pathway.
Event or Problem Description
It was reported that removal difficulty and stent movement on the balloon occurred.The procedure was performed to treat a lesion in the non-tortuous right coronary artery (rca).An 8f non-boston scientific guide catheter and a 6f guidezilla ii guide extension catheter was used.The lesion was pre-dilated using multiple balloons, along with rotational atherectomy (rotablator) and intravascular lithotripsy (shockwave).A 3.00 x 38 mm synergy xd drug-eluting stent was advanced for deployment.During advancement, resistance was encountered as the stent interacted with the 6f guidezilla ii guide extension catheter.The stent was advanced past the guidezilla helix collar and inserted into the lesion.Upon attempted deployment, the balloon failed to inflate, and inflation was aborted.The stent could not be retracted into the guidezilla ii, and the entire system was removed together.Upon removal, the stent was visibly damaged and smashed on the balloon, with damage occurring during both advancement and withdrawal.Additional damage was noted on the guidezilla ii.Although the stent remained on the balloon, it had shifted from its original position.The system was successfully removed using the stent delivery system (sds), and the procedure was completed with a different device without any patient complications.

• 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: 22001668
• Report Number: 2124215-2025-28478
• Device Sequence Number: 9042923
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: (01)08714729981015(17)270113(10)35712112
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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 Model Number: H7493941838300
• Device Catalogue Number: H7493941838300
• Device Lot Number: 0035712112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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