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

Model Number	H7493941848350
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.50 x 48mm synergy xd drug-eluting stent was selected for use.However, it was found that the stent seemed partially deployed in the guide.The procedure was completed with a different device.There was no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.50 x 48mm synergy xd drug-eluting stent was selected for use.However, it was found that the stent seemed partially deployed in the guide.The procedure was completed with a different device.There was no patient complications reported.It was further reported that resistance was felt during advancing into the guide.The unexpanded stent pulled back into the guide catheter and removed from the body due to resistance.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.50 x 48mm synergy xd drug-eluting stent was selected for use.However, it was found that the stent seemed partially deployed in the guide.The procedure was completed with a different device.There was no patient complications reported.It was further reported that resistance was felt during advancing into the guide.And the unexpanded stent pulled back into the guide catheter and removed from the body due to resistance.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy xd mr us 3.50 x 48mm was returned for analysis.A visual and tactile examination was performed and multiple kinks were identified along the hypotube shaft.Visual and microscopic inspection revealed the stent struts were lifted and pulled from mid-section over distal balloon cone and bumper tip.There were no kinks or damages on the shaft polymer extrusion.No issues were noted with the tip of the device.A microscopic examination of the proximal and distal markerbands identified no damage.The undamaged crimped stent outer diameter was measured within max crimped stent profile measurement.The device could be tracked or loaded on a guidewire without issue however due to the damage on the stent it was not possible to load the device onto a guide catheter.B3: date of event: used first date of the month since exact event date was not 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 MN 55311 ; EI 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22237222
• Report Number: 2124215-2025-38875
• Device Sequence Number: 8185705
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: (01)08714729985235
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 08/13/2025

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: H7493941848350
• Device Catalogue Number: H7493941848350
• Device Lot Number: 0035750790
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/28/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/03/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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