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

Model Number	H7493941848350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that stent fracture occurred requiring additional intervention.The 80 to 90% stenosed target lesion was located in the severely tortuous and calcified mid right coronary artery (rca).A 3.50x48 mm synergy xd drug-eluting stent (des) was deployed, and post-dilated with a 3.5x15mm non-boston scientific (bsc) non-compliant (nc) balloon.A 4.0x38 mm synergy xd des was overlapped and post-dilated using a 4.0 non-bsc nc balloon.A 3.5 nc balloon was then placed to post-dilate in between stents but it failed to pass.The non-bsc guide catheter, guideliner, and guidewire all came back and unknowingly, the guidewire went subintimal at some point.An attempt to cross the 3.5 nc balloon again, but it still failed.The stent was found to be deformed, and distal rca staining was noted distal to the original 3.5x48mm synergy xd des.The patient experienced pain and st elevation on the electrocardiogram after the flow limiting dissection.Angiography and intravascular ultrasound (ivus) confirmed that the stent was fractured into two pieces.The non-bsc wire was replaced, and another attempt was made to cross with the 3.5 nc balloon, along with a 2.75x24mm synergy xd des which was inserted multiple times in an attempt to tamponade the stain, but without success.Additionally, a 2.75x24mm synergy xd des was advanced but could not pass through the new guide extension.The stent was removed and found to be deformed.Subsequently, both 2.0 and 1.5 unknown balloons were used to tamponade the distal staining.The non-bsc guide catheter was switched for a non-bsc guide extension.Rewiring and buddy wiring were performed; however, ivus confirmed a short subintimal tract with the deformed stent.A 3.0x28mm synergy des was deployed at the dissection site, and a 4.0x28mm synergy megatron des was placed in the mid-rca to tack the malformed stent.The procedure was completed, and the patient was stable and expected to fully recover.It is noted that in opinion of the operating physician; the guidewire, guide and guide extension caused/contributed to the dissection.

• 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: 21952362
• Report Number: 2124215-2025-25950
• Device Sequence Number: 15587173
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: (01)08714729985235
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/02/2025

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 Model Number: H7493941848350
• Device Catalogue Number: H7493941848350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White