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

Model Number	H7493941848350
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred which resulted to additional intervention.The target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment but not easily pass further.The physician decided to remove the stent and not deploy.Another manufacturer was selected as the second stent.Upon removal, the stent and delivery balloon were caught, and the shaft appeared to break proximal to the stent and balloon.The stent and balloon remained lodged in the ostial portion of the lesion.The remainder of the catheter was removed, and the physician attempted to retrieve it with several techniques, including snare, balloon, and guidewire retrieval.Retrieval was unsuccessful, and surgery was recommended for the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 48mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break 120.6cm distal to the distal end of the strain relief and multiple hypotube kinks along the length of the hypotube shaft.The detached portion of the device including the stent was not returned.A review of the angiographic video and still image capture a detached distal section containing a damaged stent and the delivery balloon of the synergy xd device.The angiographic video shows the distal detached section of the device containing an undeployed, damaged stent on a delivery balloon outside the guide and free moving.A snare is in place near the tip section of the synergy xd device.Any retrieval attempts with the snare is not captured in the media.Stent deformation is noted on the stent with the proximal to mid-section appearing to have been pulled distally on the balloon.From the location of the proximal and distal markerbands there is evidence of excessive tensile force having been applied to the device resulting in the shaft stretching (as evident in the positioning of the markerbands) and breaking.From the still angiographic image review there is evidence that an interaction between the proximal section of the crimped stent and the distal end of the guide catheter occurred.The media does not capture the shaft detachment occurring.
Event or Problem Description
It was reported that shaft break occurred which resulted to additional intervention.The target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment but not easily pass further.The physician decided to remove the stent and not deploy.Another manufacturer was selected as the second stent.Upon removal, the stent and delivery balloon were caught, and the shaft appeared to break proximal to the stent and balloon.The stent and balloon remained lodged in the ostial portion of the lesion.The remainder of the catheter was removed, and the physician attempted to retrieve it with several techniques, including snare, balloon, and guidewire retrieval.Retrieval was unsuccessful, and surgery was recommended for the patient.

• 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: 23391567
• Report Number: 2124215-2025-74432
• Device Sequence Number: 10038820
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: (01)08714729985235(17)260903(10)34841554
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: H7493941848350
• Device Catalogue Number: H7493941848350
• Device Lot Number: 0034841554
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown