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

Model Number	H7493941824350
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and balloon detachment occurred resulting in surgical intervention.The target lesions were located in the left main coronary artery (lmca), left anterior descending artery (lad), and left circumflex artery (lcx).After a 7f non-boston scientific (bsc) sheath was inserted within the existing impella sheath using a single-access technique, a 7f non-bsc guide catheter was advanced in the ostium of lmca.Then, two separate non-bsc guidewires were advanced into the lcx and lad, and pre-dilated the lesions with 2.5mm nc emerge balloon catheters.Following pre-dilation, an intravascular lithotripsy was performed using a 3.0 x 12mm shockwave balloon to treat the lmca and lad.Subsequently, a 3.5x28mm synergy drug-eluting stent (des) was deployed in the ostial lmca to proximal lad, followed by 3.50 x 24mm synergy xd des in the ostial lmca to proximal lcx.These were post-dilated at high pressure and finished with simultaneous kissing balloon inflation to achieve a final lmca diameter of 6 mm.The final result showed excellent blood flow (timi 3), with no residual narrowing, dissections, blockages, or complications, and the patient was not suitable for atherectomy.However, during removal of the stent delivery system from the lcx, the shaft broke, separated the balloon from the main shaft and left inside the patient.Attempts were made to retrieve the device with a snare but was unsuccessful.The case was discussed, and to avoid potentially dislodging the implanted stent or causing vessel injuries, the patient was immediately transferred to a tertiary center for a coronary artery bypass graft.All wires and catheters were removed at the end, and the impella and sheaths were secured in place.No further patient complications were reported.

• 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: 22089539
• Report Number: 2124215-2025-31177
• Device Sequence Number: 6947607
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: (01)08714729981060(17)260827(10)34802180
• 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
• Report Date (Section B): 05/27/2025

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 Expiration Date: 08/27/2026
• Device Model Number: H7493941824350
• Device Catalogue Number: H7493941824350
• Device Lot Number: 0034802180
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 08/27/2024
• 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: 83 YR
• Patient Sex: Female